Healthcare Sales & Marketing Network News: U.S. Food and Drug Administration

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HSMN NewsFeed - 26 Aug 2026
Spineart and eCential Robotics Receive FDA 510(k) Clearance for The PERLA(R) TL Application for Use With eCential(R) Op.n(R) Navigation System for Robotic Procedures
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 24 Aug 2026
Quest Diagnostics to Offer FDA-Cleared Roche pTau217 Blood Test to Assess Alzheimer's Disease Pathology
Diagnostics Neurology FDA

HSMN NewsFeed - 18 Aug 2026
Amygdala Neurosciences Announces FDA Clearance of Investigational New Drug (IND) Application for ANS-858
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Aug 2026
Vesalio Announces FDA 510(k) Clearance of pVasc NET, a Next-Generation Peripheral Mechanical Thrombectomy Device with Integrated Distal Filter
Devices Interventional FDA

HSMN NewsFeed - 12 Aug 2026
BD Accelerates Advanced Tissue Regeneration Strategy with Landmark PREVENT Trial
Devices Surgery

HSMN NewsFeed - 10 Aug 2026
Labcorp Announces FDA Approval of Companion Diagnostic Supporting Patients with Advanced Melanoma
Diagnostics Oncology FDA

HSMN NewsFeed - 4 Aug 2026
Galaxy Therapeutics Achieves CE Mark for SEAL(TM) Embolization System, Enabling Commercial Launch Across Europe and International Markets
Devices Neurology Interventional Regulatory

HSMN NewsFeed - 30 Jul 2026
CereVasc Opens New Massachusetts Facility in Preparation for eShunt(R) System Commercialization
Devices Neurosurgery

HSMN NewsFeed - 28 Jul 2026
BrainStorm Appoints Former FDA Associate Commissioner Peter J. Pitts as Executive Chairman
Regenerative Medicine Neurology Personnel

HSMN NewsFeed - 27 Jul 2026
IceCure Medical Kicks Off its Post-Marketing "ChoICE" Study for the Low-Risk Breast Cancer Treatment at First U.S Clinical Site
Devices Oncology

HSMN NewsFeed - 24 Jul 2026
Roche Receives FDA Clearance for the Cobas(R) BV/CV Assay, Enabling Fast and Highly Accurate Vaginitis Diagnosis
Diagnostics FDA

HSMN NewsFeed - 16 Jul 2026
Lilly to Acquire AtaiBeckley to Advance Therapies for Treatment-Resistant Depression and Other Mental Health Conditions
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 6 Jul 2026
IceCure Highlights Expanding Commercial Adoption of ProSense(TM) Cryoablation in Brazil Following FDA Clearance for Breast Cancer
Devices Oncology

HSMN NewsFeed - 24 Jun 2026
ADC Therapeutics Announces Strategic Reorganization to Support ZYNLONTA(R) Growth Opportunities and Regulatory Priorities
Biopharmaceuticals Oncology

HSMN NewsFeed - 23 Jun 2026
CereVasc, Inc. Completes Enrollment in STRIDE Pivotal Trial of the eShunt(R) System
Devices Neurosurgery

HSMN NewsFeed - 22 Jun 2026
Labcorp Announces Nationwide Availability of ColoSense(R), the First FDA-Approved RNA-Based At-Home Colorectal Cancer Screening Test
Diagnostics Oncology FDA

HSMN NewsFeed - 9 Jun 2026
SpinaFX Medical receives FDA Investigational Device Exemption (IDE) for Triojection(R), its Breakthrough, Minimally-Invasive, Image-Guided Lumbar Disc Treatment
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 29 May 2026
SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
Devices Surgery FDA

HSMN NewsFeed - 19 May 2026
FRACTURE IDE trial of the Boston Scientific SEISMIQ(TM) 4CE Coronary Intravascular Lithotripsy Catheter Meets Primary Safety and Effectiveness Endpoints
Devices Interventional Cardiology

HSMN NewsFeed - 11 May 2026
Partner Therapeutics Announces FDA Approval of BIZENGRI(R) (Zenocutuzumab-zbco) for NRG1 Fusion-Positive Cholangiocarcinoma Following Receipt of FDA Commissioner's National Priority Voucher
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 May 2026
Harbour BioMed Announces U.S. FDA IND Clearance for HBM7004 for the Treatment of Advanced Solid Tumors
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Apr 2026
Sonorous Neurovascular Receives FDA 510(k) Clearance for BosCATH(TM) Neurovascular Catheter
Devices Neurology Interventional FDA

HSMN NewsFeed - 22 Apr 2026
Labcorp Launches FDA-Approved Companion Diagnostic to Identify Patients with Ovarian Cancer Eligible for KEYTRUDA(R)
Diagnostics Oncology FDA

HSMN NewsFeed - 17 Apr 2026
Corify Care Receives FDA Clearance for ACORYS(R) -- Introducing Instant, 4-D Electroanatomical Cardiac Mapping in Real-time
Devices Cardiology FDA

HSMN NewsFeed - 15 Apr 2026
Labcorp Launches FDA-Cleared Fentanyl Test Delivering Results in 10 Minutes
Diagnostics Product Launch FDA

HSMN NewsFeed - 2 Apr 2026
Zeto Announces FDA 510(k) Clearance of Zeto New Wave(TM), Advancing Efficiency in Outpatient EEG
Devices FDA

HSMN NewsFeed - 30 Mar 2026
Boston Scientific receives FDA clearance for the Asurys(TM) Fluid Management System
Devices Surgery FDA

HSMN NewsFeed - 27 Mar 2026
Otsuka Pharmaceutical to Acquire Transcend Therapeutics
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 11 Mar 2026
ARTHEx Biotech Granted FDA Fast Track Designation for ATX-01 for the Treatment of Myotonic Dystrophy Type 1 (DM1)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 6 Mar 2026
U.S. FDA Approves TECVAYLI(R) in Combination with DARZALEX FASPRO(R) for Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology Drug Delivery FDA

HSMN NewsFeed - 5 Mar 2026
Mitria Medical Announces First Use of Novel Mitral Valve Repair Device in U.S. Under Single Patient Expanded Access
Devices Cardiology Interventional

HSMN NewsFeed - 26 Feb 2026
Brainstorm Cell Therapeutics Secures Second $1 Million Strategic Placement; Total $2 Million Raised In February
Regenerative Medicine Neurology Venture Capital

HSMN NewsFeed - 25 Feb 2026
Vanda Pharmaceuticals Announces FDA Acceptance of Biologics License Application Filing for Imsidolimab for the Treatment of Generalized Pustular Psoriasis
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Feb 2026
Brainstorm Cell Therapeutics Announces $1 Million Strategic Financing at Premium to Market
Regenerative Medicine Neurology Venture Capital

HSMN NewsFeed - 11 Feb 2026
Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease Assessment in Primary Care
Diagnostics Neurology Product Launch

HSMN NewsFeed - 10 Feb 2026
Vesalio Expands International Neurovascular Portfolio with CE Mark of NeVa VS and NeVa 3.0 mm and Receives Additional FDA 510(k) Clearance for its Aspiration Catheters
Devices Neurology Interventional Regulatory

HSMN NewsFeed - 29 Jan 2026
FDA Qualifies MolecuLightDX Wound Measurement as a Medical Device Development Tool (MDDT) for Evaluating New Products in Wound Care
Devices Wound Care FDA

HSMN NewsFeed - 28 Jan 2026
REGENXBIO Announces Regulatory Update on Ultra Rare MPS Programs
Regenerative Medicine FDA

HSMN NewsFeed - 26 Jan 2026
StemCyte Announces FDA Clearance of Expanded Access Program for RegeneCyte(R) (HPC, Cord Blood) to Address Unmet Need in Long COVID
Regenerative Medicine FDA

HSMN NewsFeed - 23 Jan 2026
Affera(TM) momentum continues as Medtronic announces CE Mark in Europe and U.S. IDE First Cases for Sphere-360™ PFA Catheter to Treat Paroxysmal Atrial Fibrillation
Devices Interventional Cardiology Regulatory

HSMN NewsFeed - 19 Jan 2026
FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to iRegene's NouvNeu001, Making It the World's First iPSC Therapy with Both FTD and RMAT Recognitions
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 15 Jan 2026
BD Receives FDA 510(k) Clearance for EnCor EnCompass(TM) Breast Biopsy and Tissue Removal System
Devices FDA

HSMN NewsFeed - 12 Jan 2026
Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants
Devices Neurology FDA

HSMN NewsFeed - 5 Jan 2026
ScinoPharm Secures U.S. FDA Approval for Glatiramer Acetate Injection for the Treatment of Multiple Sclerosis
Biopharmaceuticals Generics Neurology FDA

HSMN NewsFeed - 30 Dec 2025
HAI Solutions Receives FDA De Novo Grant for QIKCAP System: Pioneering UVC Technology for Microbial Reduction on Needleless IV Connectors
Devices FDA

HSMN NewsFeed - 29 Dec 2025
FDA Accepts for Review INOVIO's BLA for INO-3107 for the Treatment of Adults with Recurrent Respiratory Papillomatosis (RRP)
Biopharmaceuticals FDA

HSMN NewsFeed - 23 Dec 2025
Zydus Partners with Bioeq for U.S. Commercialisation rights for NUFYMCO(R), an Interchangeable Biosimilar to Lucentis(R)
Biopharmaceuticals Licensing

HSMN NewsFeed - 22 Dec 2025
U.S. FDA Approves JASCAYD(R) (nerandomilast) Tablets for the Treatment of Progressive Pulmonary Fibrosis in Adults
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Dec 2025
BioMarin to Acquire Amicus Therapeutics for $4.8 Billion, Expanding Position as a Leader in Rare Diseases, Accelerating Revenue Growth and Strengthening Financial Outlook
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 8 Dec 2025
EyeYon Medical Ltd. Receives FDA IDE Approval to Initiate U.S. Clinical Study of EndoArt(R), the First Artificial Endothelial Layer for Corneal Edema
Devices Ophthalmology FDA

HSMN NewsFeed - 28 Nov 2025
Vanda Pharmaceuticals Provides Regulatory Update on Tradipitant for Motion Sickness
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Nov 2025
Piccolo Medical(R) Receives FDA Clearance to Expand ECGuide(TM) Technology Use to Pediatric and Neonatal Patients
Devices FDA

HSMN NewsFeed - 14 Nov 2025
Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA(R) Knee Robotic Technology
Devices Orthopaedic FDA

HSMN NewsFeed - 13 Nov 2025
icotec Receives FDA Clearance for the CMORE(R) CT System, Expanding its BlackArmor(R) Engineered Carbon/PEEK Technology to the Posterior Cervicothoracic Spine
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 10 Nov 2025
Freenome Appoints Industry Veteran Rob Guigley as Chief Commercial Officer to Drive Commercial Strategy, As Agreement with Exact Sciences Clears Antitrust Review
Diagnostics Personnel

HSMN NewsFeed - 7 Nov 2025
Gore Announces Positive Clinical Trial Results of the Investigational Gore(R) Viabahn(R) Fortegra Venous Stent for Treatment of Patients With Deep Venous Iliocaval Obstruction
Devices Interventional

HSMN NewsFeed - 3 Nov 2025
Alcresta Therapeutics Announces FDA Clearance for Expanded Use of RELiZORB(R) (iMMOBILIZED LIPASE) Cartridge for Neonates and Infants
Biopharmaceuticals FDA

HSMN NewsFeed - 28 Oct 2025
Zimmer Biomet Announces FDA Breakthrough Designation for World's First Iodine-Treated Total Hip Replacement System
Devices Orthopaedic FDA

HSMN NewsFeed - 27 Oct 2025
Hemab Therapeutics Announces $157 Million Series C Financing to Advance Next-Generation Treatments for Underserved Bleeding Disorders
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 24 Oct 2025
Terumo Interventional Systems Announces Its New OPUSWAVE(R) Dual Sensor Imaging System and DualView(R) Imaging Catheter Receive FDA 510(k) Clearance
Devices Interventional Cardiology FDA

HSMN NewsFeed - 23 Oct 2025
Labcorp to Offer First FDA-Cleared Blood Test to Rule out Alzheimer's-Related Amyloid Pathology in Primary Care Settings
Diagnostics Neurology

HSMN NewsFeed - 21 Oct 2025
Onkos Surgical(R) Receives FDA 510(k) Clearance for ELEOS(TM) Proximal Tibia with NanoCept(R) Antibacterial Technology
Devices Orthopaedic FDA

HSMN NewsFeed - 17 Oct 2025
Boston Scientific Announces Agreement to Acquire Nalu Medical, Inc.
Devices Neurology Mergers & Acquisitions

HSMN NewsFeed - 15 Oct 2025
CAPS Medical's PlasmaSure(TM) Receives FDA Breakthrough Device Designation
Devices Oncology FDA

HSMN NewsFeed - 13 Oct 2025
Zeta Surgical(R) AI-powered TMS Navigation System Receives FDA 510(k) Clearance
Devices Neurology FDA

HSMN NewsFeed - 10 Oct 2025
Next-Generation AI-Driven SyncAR(R) Spine Receives FDA Clearance for Spine Surgery
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 6 Oct 2025
Alcresta Therapeutics Expands Executive Leadership to Drive Strategic Initiatives
Biopharmaceuticals Personnel

HSMN NewsFeed - 19 Sep 2025
Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion(TM) BCP-PEEK Implant
Devices Neurosurgery FDA

HSMN NewsFeed - 18 Sep 2025
J & D Pharmaceuticals LLC Receives Orphan Drug Designation for Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Biopharmaceuticals FDA

HSMN NewsFeed - 9 Sep 2025
ARTBIO Announces FDA Clearance of IND Application for Lead Alpha Radioligand Therapy AB001
Devices Oncology FDA

HSMN NewsFeed - 8 Sep 2025
FDA Accepts Letter of Intent to Qualify LSM by VCTE (FibroScan(R)) as First Non-Invasive Surrogate Endpoint in MASH Clinical Trials
Diagnostics FDA

HSMN NewsFeed - 4 Sep 2025
Sentec Receives FDA Clearance for LuMon(TM) Electrical Impedance Tomography (EIT) System -- First EIT System Indicated for Premature Infants and for Spontaneously Breathing Patients in the United States
Devices Monitoring FDA

HSMN NewsFeed - 4 Sep 2025
4DMedical's CT:VQ(TM) Receives FDA 510(k) Clearance; First-and-Only CT-Based VQ Technology
Devices Radiology FDA

HSMN NewsFeed - 21 Aug 2025
FDA Clearance of Salix(R) Coronary Plaque Module
Devices Cardiology FDA

HSMN NewsFeed - 20 Aug 2025
CytoSorbents Updates U.S. FDA Regulatory Status of DrugSorb-ATR
Devices FDA

HSMN NewsFeed - 18 Aug 2025
Labcorp Launches First FDA-Cleared Blood Test for Alzheimer's Disease
Diagnostics Neurology Product Launch

HSMN NewsFeed - 5 Aug 2025
Hemispherian Receives FDA IND Clearance for First-in-Class Glioblastoma Therapeutic, GLIX1
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Jul 2025
BD Receives FDA 510(k) Clearance for Rapid Point-of-Care COVID-19 Test
Diagnostics FDA

HSMN NewsFeed - 29 Jul 2025
Leo Cancer Care Receives FDA 510(k) Clearance for Marie(R) - A Revolutionary Upright Radiotherapy Platform
Devices Oncology FDA

HSMN NewsFeed - 22 Jul 2025
SPRITAM(R) (levetiracetam) Tablets for Oral Suspension Approved by FDA for Nasogastric and Gastrostomy Tube Administration
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 16 Jul 2025
Piccolo Medical, Inc. Receives FDA Clearance for 2nd Generation SmartPICC(R) Technology
Devices FDA

HSMN NewsFeed - 11 Jul 2025
Tomoverse Imaging Inc. Announces Closing of $5 Million Dollar Seed Funding Round Led by Strategic Canadian Family Office
Devices Radiology Cardiology Venture Capital

HSMN NewsFeed - 10 Jul 2025
Klotho Neurosciences, Inc. Granted FDA Orphan Drug Designation for KLTO-202 for Treatment of Amyotrophic Lateral Sclerosis ("ALS" or "Lou Gehrig's Disease")
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 8 Jul 2025
Soligenix Corporate Update Letter - Key Highlights and Upcoming Milestones
Biopharmaceuticals Oncology

HSMN NewsFeed - 7 Jul 2025
Boston Scientific Receives FDA Approval for Expanded Labeling of FARAPULSE(TM) Pulsed Field Ablation System
Devices Interventional Cardiology FDA

HSMN NewsFeed - 2 Jul 2025
Moon Surgical Receives FDA Clearance for Maestro(TM) Connectivity and Predetermined Change Control Plan for AI-Powered ScoPilot(R)
Devices Surgery FDA

HSMN NewsFeed - 25 Jun 2025
Viking Therapeutics Announces Initiation of Phase 3 Obesity Clinical Program with GLP-1/GIP Agonist VK2735
Biopharmaceuticals Endocrinology

HSMN NewsFeed - 20 Jun 2025
Lomond Therapeutics Announces U.S. FDA Clearance of IND Application for Lonitoclax, a Selective BCL2 Inhibitor with Limited Immune Suppression and Improved Safety Compared to Venetoclax and Venetoclax- Like Molecules
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Jun 2025
TYBR Health Announces FDA 510(k) Clearance for B3 GEL(TM) System, a Flowable Bio-Gel to Protect Healing Tissue and Preserve Function
Devices Regenerative Medicine Surgery FDA

HSMN NewsFeed - 5 Jun 2025
Penumbra Introduces the Ruby(R) XL System - the Longest, Largest, and Softest Coil on the Market for Vascular Embolization
Devices Interventional FDA Product Launch

HSMN NewsFeed - 3 Jun 2025
Amber Implants Announces Successful One-Year Follow-Up Data in First-in-Human Clinical Trial of VCFix(R) Spinal System
Devices Orthopaedic Neurosurgery

HSMN NewsFeed - 27 May 2025
BrainStorm Secures Key Manufacturing Partnership with Minaris for Upcoming NurOwn(R) Phase 3b ALS Clinical Trials
Regenerative Medicine Neurology

HSMN NewsFeed - 19 May 2025
BrainStorm Receives FDA Clearance to Initiate Phase 3b Trial of NurOwn(R) for ALS
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 29 Apr 2025
Lutris Pharma Announces the Appointment of Seasoned Life Science Executive, Sumant Ramachandra, M.D., Ph.D., as Chief Executive Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 24 Apr 2025
Medtronic Advances Abbott CGM Partnership with FDA Submission of Interoperable Insulin Pump
Devices Endocrinology FDA

HSMN NewsFeed - 11 Apr 2025
Turbett Surgical Receives FDA 510(k) Clearance for Enhanced Instrument Pod Portfolio
Devices Surgery FDA

HSMN NewsFeed - 10 Apr 2025
BrainStorm Cell Therapeutics Submits IND Amendment to FDA, Paving the Way for Phase 3b Trial of NurOwn(R) in ALS
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 7 Apr 2025
ICU Medical Introduces Its New Category of Infusion Devices With FDA Clearances of Plum Solo(TM) and Plum Duo(TM) Precision IV Pumps
Devices Drug Delivery FDA

HSMN NewsFeed - 4 Apr 2025
Neurocrine Biosciences Appoints Dr. Sanjay Keswani as Chief Medical Officer
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 24 Mar 2025
Newronika Receives CE Mark Approval for AlphaDBS, Advancing Adaptive Deep Brain Stimulation for Parkinson's Disease
Devices Neurology Regulatory

HSMN NewsFeed - 7 Mar 2025
Zimmer Biomet Receives FDA Clearance for Persona(R) Revision SoluTion(TM) Femur
Devices Orthopaedic FDA

HSMN NewsFeed - 5 Mar 2025
Jazz Pharmaceuticals to Acquire Chimerix, Further Diversifying Oncology Portfolio
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 26 Feb 2025
ABANZA Receives FDA 510(k) Clearance for WasherCap(TM) Mini Implantable Fixation Device
Devices Orthopaedic FDA

HSMN NewsFeed - 21 Feb 2025
FDA Declares Wegovy(R) and Ozempic(R) Shortage is Over and that Novo Nordisk is Fully Meeting or Exceeding Nationwide Demand for All Doses
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Feb 2025
Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 5 Feb 2025
Newronika Receives Investigational Device Exemption (IDE) from FDA to Initiate U.S. Clinical Trial of Adaptive DBS System
Devices Neurology FDA

HSMN NewsFeed - 31 Jan 2025
U.S. FDA Approves Celltrion's AVTOZMA(R) (tocilizumab-anoh), a Biosimilar to ACTEMRA(R)
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 30 Jan 2025
Coeptis Therapeutics Holdings Becomes COEPTIS: Embracing a Future of Technology and Innovation
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 17 Jan 2025
FDA Approves LUMAKRAS(R) (Sotorasib) in Combination with Vectibix(R) (Panitumumab) for Chemorefractory KRAS G12C-Mutated Metastatic Colorectal Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 15 Jan 2025
New Drug Application Initiated with U.S. FDA for TAR-200, the First and Only Intravesical Drug Releasing System for Patients with BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer
Biopharmaceuticals Drug Delivery Oncology FDA

HSMN NewsFeed - 13 Jan 2025
Cresilon Announces U.S. Nationwide Launch of TRAUMAGEL
Devices FDA

HSMN NewsFeed - 8 Jan 2025
Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive U.S. FDA Fast Track Designations for the Treatment of Alzheimer's Disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 2 Jan 2025
Movano Health Welcomes Dr. Shaheen Wirk to its Board of Directors
Devices Monitoring Personnel

HSMN NewsFeed - 30 Dec 2024
Halozyme Announces FDA Approval of Bristol Myers Squibb's Opdivo Qvantig(TM) with ENHANZE(R) for Subcutaneous Use in Most Previously Approved Adult Solid Tumor Opdivo(R) (nivolumab) Indications
Biopharmaceuticals Drug Delivery Oncology FDA

HSMN NewsFeed - 26 Dec 2024
Coeptis Therapeutics Makes Bold Strides in Innovation with the Acquisition of NexGenAI Affiliates Network Platform and Launch of Coeptis Technologies
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 20 Dec 2024
Neurocrine Biosciences Announces Commercial Availability of CRENESSITY(TM) (crinecerfont) for Children and Adults With Classic Congenital Adrenal Hyperplasia
Biopharmaceuticals Product Launch

HSMN NewsFeed - 13 Dec 2024
Zimmer Biomet Receives FDA Clearance for OsseoFit(TM) Stemless Shoulder System for Total Shoulder Replacement
Devices Orthopaedic FDA

HSMN NewsFeed - 12 Dec 2024
U.S. FDA Expands Indication for Impella Heart Pumps to Treat Pediatric Patients
Devices Cardiology FDA

HSMN NewsFeed - 27 Nov 2024
PTC Therapeutics Enters into Agreement to Sell Priority Review Voucher for $150 Million
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Nov 2024
U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE(TM) Cord Blood Cell Therapy Product
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Nov 2024
Medtronic Receives FDA Clearance for New InPen(TM) App, Paving the Way for its Smart MDI System Launch with Simplera(TM) CGM
Devices Monitoring FDA

HSMN NewsFeed - 19 Nov 2024
THINK Surgical Receives FDA 510(k) Clearance to Use Freedom(R) Total Knee, Freedom Titan(R) Knee, and Freedom Primary PCK(R) System Implants with TMINI(R) Miniature Robotic System
Devices Orthopaedic FDA

HSMN NewsFeed - 12 Nov 2024
Nevro's HFX iQ(TM) Spinal Cord Stimulation with AI Technology Receives CE Mark Certification in Europe, Increasing Product Expansion Globally
Devices Regulatory

HSMN NewsFeed - 11 Nov 2024
Momentis Surgical Receives FDA 510(k) Clearance for Second Generation Anovo(R) Robotic Platform, Introducing Haptic Feedback and Dual-Mode Articulation
Devices Surgery FDA

HSMN NewsFeed - 8 Nov 2024
FDA Advisory Panel Votes in Favor of IceCure's ProSense(R) Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
Devices Oncology FDA

HSMN NewsFeed - 4 Nov 2024
Boston Scientific Announces Agreement to Acquire Cortex, Inc.
Devices Cardiology Mergers & Acquisitions

HSMN NewsFeed - 1 Nov 2024
CARsgen(R) U.S. Clinical Holds Lifted by FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Oct 2024
FDA Grants Orphan Drug Designation to Capsida Biotherapeutics for Potential Treatment of STXBP1 Developmental and Epileptic Encephalopathy
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Oct 2024
Protega Pharmaceuticals Receives FDA Approval for ROXYBOND(TM) (oxycodone hydrochloride) Immediate-Release 10 mg Tablet with Abuse-Deterrent Technology for Management of Pain
Biopharmaceuticals FDA

HSMN NewsFeed - 24 Oct 2024
Accent Therapeutics Announces FDA Clearance of IND Application for ATX-559, a First-In-Class Oral DHX9 Inhibitor
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 11 Oct 2024
X-Bolt Announces First U.S. Implant of Pro-X1(R) Trochanteric Nailing System
Devices Orthopaedic Product Launch

HSMN NewsFeed - 9 Oct 2024
ShiraTronics Raises $66 Million in Oversubscribed Series B Financing to Advance Pioneering Treatment for Chronic Migraine
Devices Neurology Venture Capital

HSMN NewsFeed - 9 Oct 2024
Inspira(TM) Announces Development of New Disposable Kit with Built-In Performance Monitoring Mechanism
Devices

HSMN NewsFeed - 3 Oct 2024
Avidity Biosciences Announces FDA Removed Partial Clinical Hold on Delpacibart Etedesiran (del-desiran/AOC 1001)
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Sep 2024
Heron Therapeutics Announces FDA Approval of the Prior Approval Supplement Application for ZYNRELEF(R) Vial Access Needle ("VAN")
Devices Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 24 Sep 2024
B. Braun Medical Receives FDA Clearance for Introcan Safety(R) 2 Deep Access IV Catheter
Devices FDA

HSMN NewsFeed - 23 Sep 2024
UCB Announces U.S. FDA Approvals for BIMZELX(R) (bimekizumab-bkzx) for the Treatment of Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis, and Ankylosing Spondylitis
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Sep 2024
FDA Declines to Approve Vanda's Marketing Application for Tradipitant in Gastroparesis
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Sep 2024
Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI(TM) (trastuzumab-strf), a biosimilar to Herceptin(R) (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer
Biopharmaceuticals Generics Oncology FDA

HSMN NewsFeed - 17 Sep 2024
Boston Scientific Receives FDA Approval for Expanded Indication of INGEVITY(TM)+ Pacing Leads to Include Conduction System Pacing of the Left Bundle Branch Area
Devices Cardiology FDA

HSMN NewsFeed - 12 Sep 2024
Inflammatix Secures $57 Million to Advance Novel Diagnostic for Patients with Suspected Infections or Sepsis
Diagnostics Venture Capital

HSMN NewsFeed - 28 Aug 2024
Neuros Medical Receives FDA Approval for the Altius(R) Direct Electrical Nerve Stimulation System
Devices FDA

HSMN NewsFeed - 20 Aug 2024
Pathalys Pharma Secures $105 Million Series B Financing
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 20 Aug 2024
RYBREVANT(R) (amivantamab-vmjw) Plus LAZCLUZE(TM) (lazertinib) Approved in the U.S. as a First-line Chemotherapy-free Treatment for Patients with EGFR-mutated Advanced Lung Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Aug 2024
FDA Approves First Nasal Spray for Treatment of Anaphylaxis
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 8 Aug 2024
Sobi and Apellis announce positive topline results from phase 3 VALIANT study of pegcetacoplan in C3G and primary IC-MPGN
Biopharmaceuticals

HSMN NewsFeed - 29 Jul 2024
Syndax Announces PDUFA Action Date Extension for Revumenib NDA for Relapsed or Refractory KMT2Ar Acute Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Jul 2024
Latigo Biotherapeutics Appoints Nima Farzan as Chief Executive Officer, Positioning Company for Rapid Growth
Biopharmaceuticals Personnel

HSMN NewsFeed - 27 Jun 2024
VenoStent Completes $20 Million Series A with $4 Million Investment from Norwest Venture Partners
Devices Venture Capital

HSMN NewsFeed - 26 Jun 2024
BrainStorm Cell Therapeutics Reaches Alignment with FDA on CMC Aspects of Phase 3b NurOwn(R) Clinical Trial
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 24 Jun 2024
Harmony Biosciences Receives U.S. Food And Drug Administration Approval For Wakix(R) (Pitolisant) In Pediatric Patients With Narcolepsy
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 21 Jun 2024
FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific Review
Drug Delivery FDA

HSMN NewsFeed - 20 Jun 2024
BrainStorm Cell Therapeutics Announces Appointment of Haro Hartounian Ph.D. as Chief Operating Officer
Regenerative Medicine Personnel

HSMN NewsFeed - 10 Jun 2024
Abbott Receives U.S. FDA Clearance for Two New Over-the-Counter Continuous Glucose Monitoring Systems
Devices Endocrinology Monitoring FDA

HSMN NewsFeed - 4 Jun 2024
Zeto obtains FDA 510(k) clearance for its groundbreaking next-generation EEG brain monitoring product, ONE.
Devices Neurology Monitoring FDA

HSMN NewsFeed - 30 May 2024
US FDA Awards Supplemental Orphan Drug Designation to Survaxm to Now Include Treatment of Malignant Glioma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 29 May 2024
Beckman Coulter Secures FDA Clearance for Heart Failure Assay on DxI 9000 Immunoassay Analyzer
Devices Diagnostics Cardiology FDA

HSMN NewsFeed - 28 May 2024
Terumo Cardiovascular Announces 510(K) Clearance for the CDI OneView(TM) Monitoring System
Devices Monitoring FDA

HSMN NewsFeed - 21 May 2024
Biocon Biologics Obtains U.S. FDA Approval for Biosimilar Aflibercept for Yesafili(TM). Enters U.S. Ophthalmology Market
Biopharmaceuticals Generics Ophthalmology FDA

HSMN NewsFeed - 17 May 2024
Implicity Earns FDA Clearance for New Heart Failure Prediction Algorithm
Devices Monitoring Cardiology FDA

HSMN NewsFeed - 14 May 2024
Brixton Biosciences Announces $33M in Series B Funding to Advance Novel Technology for the Treatment of Pain
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 8 May 2024
4C Medical's AltaValve System Secures Dual FDA Breakthrough Device Designations, Expediting Patient Access to Advanced Mitral Valve Therapies
Devices Interventional Cardiology FDA

HSMN NewsFeed - 3 May 2024
Leading Academic Neurosurgeons Describe New NICO Myriad SPECTRA(TM) System as a 'Game-Changing Advancement' in Surgical Removal of High-Grade Glioma Brain Tumors
Devices Neurosurgery Oncology

HSMN NewsFeed - 29 Apr 2024
Labcorp Receives FDA Approval for First Companion Diagnostic for Use with Pfizer's Newly Approved Gene Therapy to Treat Patients with Hemophilia B
Biopharmaceuticals Diagnostics FDA

HSMN NewsFeed - 16 Apr 2024
Xstim, Inc. Receives FDA Approval for Xstim(TM) Spine Fusion Stimulator
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 8 Apr 2024
Mitsubishi Tanabe Pharma America Receives U.S. Food and Drug Administration Orphan Drug Exclusivity for RADICAVA ORS(R) (edaravone)
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 28 Mar 2024
Nested Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NST-628, a Novel Pan-RAF/MEK Molecular Glue
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 22 Mar 2024
Astellas Receives Positive CHMP Opinion for XTANDI(TM) in Additional Recurrent Early Prostate Cancer Treatment Setting
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 11 Mar 2024
FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA(R) (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Mar 2024
U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 5 Mar 2024
ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices(TM) Cardiopulmonary Management (CPM) System
Devices Cardiology Monitoring FDA

HSMN NewsFeed - 1 Mar 2024
Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar(R) Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect(TM) Injector
Devices Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 1 Mar 2024
Boston Scientific Receives FDA Approval for the AGENT(TM) Drug-Coated Balloon
Devices Interventional Cardiology FDA

HSMN NewsFeed - 27 Feb 2024
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Feb 2024
BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn(R) in ALS
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 22 Feb 2024
Zimmer Biomet Receives FDA Clearance for ROSA(R) Shoulder System - the World's First Robotic Assistant for Shoulder Replacement Surgery
Devices Orthopaedic FDA

HSMN NewsFeed - 21 Feb 2024
Sira Medical Wins FDA Clearance for Augmented Reality Preoperative Surgical Planning Software
Devices Surgery FDA

HSMN NewsFeed - 20 Feb 2024
Avidity Biosciences Receives FDA Rare Pediatric Disease Designation for AOC 1044 for Treatment of Duchenne Muscular Dystrophy in People with Mutations Amenable to Exon 44 Skipping
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Feb 2024
Fusion Pharmaceuticals Enters into Exclusive Worldwide License Agreement with Heidelberg University and Euratom for Actinium-Based PSMA Targeted Radiotherapy
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 13 Feb 2024
ProfoundBio Raises $112 Million in Oversubscribed Series B Equity Financing to Advance its Clinical-Stage Antibody-Drug Conjugate (ADC) Pipeline
Biopharmaceuticals Oncology Venture Capital

HSMN NewsFeed - 12 Feb 2024
AbbVie Completes Acquisition of ImmunoGen
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 7 Feb 2024
Innova Vascular Announces Successful Early Commercial Use of Laguna Thrombectomy System(TM) in Patients
Devices Interventional

HSMN NewsFeed - 6 Feb 2024
Zynex Receives FDA Clearance for its Next Generation NMES Device
Devices FDA

HSMN NewsFeed - 23 Jan 2024
FDA Grants Breakthrough Device Designation to Amadix´s preventive screening blood test for Colorectal Cancer
Diagnostics Oncology FDA

HSMN NewsFeed - 19 Jan 2024
Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Progressive Multiple Sclerosis
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 11 Jan 2024
Zeta Surgical's Mixed Reality Navigation System Receives FDA Special 510(k) Clearance for Expanded Functionality
Devices Neurosurgery FDA

HSMN NewsFeed - 10 Jan 2024
Providence Medical Technology Announces FDA Clearance of CAVUX(R) FFS-LX Lumbar Facet Fixation System for 1- and 2-Level Lumbar Spinal Fusion
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 26 Dec 2023
Amgen Provides Regulatory Update on Status of Lumakras(R) (Sotorasib)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Dec 2023
NeuExcell's AAV Gene Therapy for Malignant Glioma Granted Orphan Drug Designation by FDA
Regenerative Medicine Neurosurgery Oncology FDA

HSMN NewsFeed - 15 Dec 2023
CymaBay Submits New Drug Application to FDA for Seladelpar for the Treatment of Primary Biliary Cholangitis
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Dec 2023
Kyverna Therapeutics Granted FDA Fast Track Designation for KYV-101 in the Treatment of Patients With Refractory Myasthenia Gravis
Biopharmaceuticals FDA

HSMN NewsFeed - 13 Dec 2023
Triveni Bio Welcomes Jeff Albers and Allison Luo to its Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 5 Dec 2023
ABK Biomedical Announces That its Eye90 Microspheres(R) Device Has Been Granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA)
Devices Oncology FDA

HSMN NewsFeed - 27 Nov 2023
RTI Surgical Inc. Receives FDA IDE Approval for the Clinical Investigation of Cortiva(R) Allograft Dermis in Breast Reconstruction
Devices Surgery FDA

HSMN NewsFeed - 24 Nov 2023
Novartis Issues Voluntary US Nationwide Recall of Two Lots of Sandimmune(R) Oral Solution (cyclosporine oral solution, USP), 100 mg/mL due to Crystallization
Biopharmaceuticals Product Recall

HSMN NewsFeed - 20 Nov 2023
FDA Grants Orphan Drug Designation to NeoImmuneTech's NT-I7 for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA

HSMN NewsFeed - 16 Nov 2023
Ad Astra Diagnostics receives 510(k) clearance of QScout(TM) hematology analyzer, the first to report measures of infection and severity at point-of-care
Diagnostics FDA

HSMN NewsFeed - 8 Nov 2023
Recor Medical and Otsuka Medical Devices Announce First FDA-Approved Renal Denervation System for the Treatment of Hypertension
Devices Cardiology FDA

HSMN NewsFeed - 2 Nov 2023
BD Advances "One-Stick Hospital Stay" Vision with Launch of Next-Generation Needle-Free Blood Draw Technology
Devices FDA Product Launch

HSMN NewsFeed - 27 Oct 2023
Laborie Medical Technologies Acquires Urotronic
Devices Urology Mergers & Acquisitions

HSMN NewsFeed - 24 Oct 2023
BrainStorm Cell Therapeutics Announces Strategic Realignment Prioritizing NurOwn(R) for the Treatment of ALS
Regenerative Medicine Neurology

HSMN NewsFeed - 23 Oct 2023
Medtronic receives FDA approval for extravascular defibrillator to treat abnormal heart rhythms, sudden cardiac arrest
Devices Cardiology FDA

HSMN NewsFeed - 18 Oct 2023
BrainStorm Cell Therapeutics to Meet with US FDA to Discuss Development Plan for NurOwn as a Treatment of ALS
Regenerative Medicine Neurology

HSMN NewsFeed - 20 Sep 2023
IceCure Medical Receives FDA Response to De Novo Classification Request for Breast Cancer
Devices FDA

HSMN NewsFeed - 19 Sep 2023
Boston Scientific Announces Agreement to Acquire Relievant Medsystems, Inc.
Devices Mergers & Acquisitions

HSMN NewsFeed - 12 Sep 2023
Protalix BioTherapeutics Appoints Eliot Richard Forster, Ph.D. as Chairman of its Board of Directors
Biopharmaceuticals Personnel

HSMN NewsFeed - 8 Sep 2023
Citius Pharmaceuticals, Inc. Receives Regulatory Guidance from the U.S. Food and Drug Administration (FDA) regarding the Planned Resubmission of the BLA for LYMPHIR(TM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 23 Aug 2023
Fresenius Medical Care Announces FDA Clearance of Versi(R)HD with GuideMe Software
Devices FDA

HSMN NewsFeed - 22 Aug 2023
Levita(R) Magnetics Wins FDA Clearance for Pioneering MARS(TM) System
Devices Surgery FDA

HSMN NewsFeed - 21 Aug 2023
magAssist's NyokAssist(TM) granted Designation by the FDA as a Breakthrough Device
Devices Interventional Cardiology FDA

HSMN NewsFeed - 18 Aug 2023
FDA grants priority review for full approval of TARPEYO for the treatment of IgA Nephropathy
Biopharmaceuticals FDA

HSMN NewsFeed - 11 Aug 2023
Zumutor Biologics Inc Announces FDA Clearance of IND Application of ZM008, a Novel Monoclonal Antibody Drug Against Multiple Solid Cancers
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Aug 2023
Baird Medical Submits Disposable Microwave Ablation Needle and MWA System Application to U.S. FDA for Treatment of Soft Tissue Microwave Ablation
Devices FDA

HSMN NewsFeed - 4 Aug 2023
Biosense Webster Receives FDA Approval for Multiple Atrial Fibrillation Ablation Products to be Used in a Workflow Without Fluoroscopy
Devices Cardiology FDA

HSMN NewsFeed - 1 Aug 2023
BD Receives 510(k) Clearance for COVID-19, Influenza A/B, RSV Molecular Combination Test
Diagnostics FDA

HSMN NewsFeed - 31 Jul 2023
Viatris Announces Launch of Breyna(TM) (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol, the First FDA-Approved Generic Version of Symbicort(R) for People with Asthma and Chronic Obstructive Pulmonary Disease, in Partnership with Kindeva
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 24 Jul 2023
BD CEO Tom Polen Addresses FDA 510(k) Clearance of BD Alaris(TM) Infusion System
Devices FDA

HSMN NewsFeed - 20 Jul 2023
Boehringer Ingelheim Receives FDA Approval for NexGard(R) PLUS (afoxolaner, moxidectin and pyrantel chewable tablets): A Beef-Flavored Soft Chew That Protects Dogs from Internal and External Parasites
Biopharmaceuticals Veterinary FDA

HSMN NewsFeed - 20 Jul 2023
MediView Receives FDA 510(k) Clearance for XR90 Augmented Reality-Based Visualization and Navigation Platform
Devices Surgery FDA

HSMN NewsFeed - 12 Jul 2023
BrainStorm Cell Therapeutics Appoints Bob Dagher, M.D., as Executive Vice President and Chief Development Officer
Regenerative Medicine Personnel

HSMN NewsFeed - 5 Jul 2023
Abbott Receives FDA Approval for World's First Dual Chamber Leadless Pacemaker
Devices Cardiology FDA

HSMN NewsFeed - 3 Jul 2023
Skyline Therapeutics Receives FDA Clearance of IND for SKG0106, a Novel Intravitreally Delivered AAV Gene Therapy Candidate for Neovascular Age-related Macular Degeneration
Regenerative Medicine Ophthalmology FDA

HSMN NewsFeed - 21 Jun 2023
Aethlon Medical Announces Investigation of the Hemopurifier(R) for Use in Organ Transplantation
Devices

HSMN NewsFeed - 19 Jun 2023
Sirnaomics Advances STP705 for Squamous Cell Carcinoma In Situ into Late-Stage Clinical Development
Biopharmaceuticals Oncology

HSMN NewsFeed - 7 Jun 2023
Innova Vascular Earns FDA Clearance for Two New Thrombectomy Devices: Laguna Clot Retriever(TM) System and Malibu Aspiration Catheter(TM) System
Devices Interventional FDA

HSMN NewsFeed - 1 Jun 2023
Penumbra Expands Computer-Aided Thrombectomy Offerings with Lightning Bolt 7 Technology Designed to Rapidly Remove Blood Clots with Modulated Aspiration
Devices Interventional Product Launch FDA

HSMN NewsFeed - 19 May 2023
Abbott Receives FDA Approval for TactiFlex(TM) Ablation Catheter for Treatment of Abnormal Heart Rhythm
Devices Interventional Cardiology FDA

HSMN NewsFeed - 16 May 2023
BD Gains 510(k) Clearance of Artificial Intelligence Software for MRSA Diagnostics
Diagnostics FDA

HSMN NewsFeed - 4 May 2023
Soligenix Announces Positive Clinical Results from Compatibility Study of HyBryte(TM) in the Treatment of Cutaneous T-Cell Lymphoma
Biopharmaceuticals Oncology

HSMN NewsFeed - 26 Apr 2023
CardieX Receives FDA 510(K) Clearance for a World-First Vascular Biometric Monitor - the CONNEQT Pulse
Devices Monitoring Cardiology FDA

HSMN NewsFeed - 21 Apr 2023
AbbVie Announces Late-Breaking Results from Phase 3 Trial Evaluating Atogepant (QULIPTA(R)) for the Preventive Treatment of Episodic Migraine Among Patients with Prior Treatment Failure at the 2023 AAN Annual Meeting
Biopharmaceuticals Neurology

HSMN NewsFeed - 18 Apr 2023
Neuspera Medical(R) Announces FDA Clearance of its System for Peripheral Nerve Stimulation
Devices Neurology FDA

HSMN NewsFeed - 13 Apr 2023
BioVentrix(R) Closes $48.5 Million Series A Financing
Devices Interventional Cardiology Venture Capital

HSMN NewsFeed - 10 Apr 2023
Reach Neuro Receives FDA Breakthrough Device Designation for Device to Restore Arm and Hand Movement to Chronic Stroke Patients
Devices Neurology FDA

HSMN NewsFeed - 6 Apr 2023
Icentia Receives U.S. Food and Drug Administration (FDA) Clearance for CardioSTAT(R)
Devices Cardiology FDA

HSMN NewsFeed - 30 Mar 2023
FDA approves Bioretec's RemeOs(TM) trauma screw as the first bioresorbable metal implant in the U.S. market
Devices Orthopaedic FDA

HSMN NewsFeed - 29 Mar 2023
CoreLink Announces FDA Clearance of Siber(R) Ti--3D Printed SI Joint Fusion System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 29 Mar 2023
Spiral Therapeutics Acquires Otonomy Assets to Boost Inner Ear Disorders Pipeline and Appoints Industry Leaders to Board
Biopharmaceuticals Acquisitions

HSMN NewsFeed - 27 Mar 2023
BrainStorm Cell Therapeutics Announces FDA Advisory Committee Meeting to Review Biologics License Application for NurOwn(R) for the Treatment of ALS
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 21 Mar 2023
U.S. FDA Grants GrayMatters Health 510(k) Clearance to Market Prism for PTSD
Devices Neurology FDA

HSMN NewsFeed - 20 Mar 2023
NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients
Devices Orthopaedic FDA

HSMN NewsFeed - 15 Mar 2023
Medtronic receives CE Mark approval for Affera(TM) Mapping and Ablation System to treat atrial arrhythmias
Devices Interventional Cardiology Regulatory

HSMN NewsFeed - 15 Feb 2023
Codagenix Announces Close of $25 million Extension of Series B
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 2 Feb 2023
Tezspire(R) Approved for Self-Administration in the U.S. with a New Pre-Filled Pen
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 30 Jan 2023
Nanoscope Therapeutics Receives Fast Track Designation by the FDA for MCO-010 for the Treatment of Stargardt Disease
Regenerative Medicine Ophthalmology FDA

HSMN NewsFeed - 26 Jan 2023
FDA Approves Abbott's Spinal Cord Stimulation for People Living with Painful Diabetic Peripheral Neuropathy
Devices Neurology FDA

HSMN NewsFeed - 23 Jan 2023
Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation
Biopharmaceuticals FDA

HSMN NewsFeed - 20 Jan 2023
Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 19 Jan 2023
Conventus Flower Orthopedics Announces Expansion of its Flex-Thread(TM) Technology Platform with FDA Clearance of the Ulna Intramedullary Nail System
Devices Orthopaedic FDA

HSMN NewsFeed - 10 Jan 2023
Arthrex Receives FDA Clearance for TightRope(R) Implant as First, Only Device Cleared for Pediatric ACL Surgery
Devices Orthopaedic FDA

HSMN NewsFeed - 5 Jan 2023
HighTide Therapeutics Raises $107 Million in Series C/C+ Financing to Advance Innovative Pipeline and Business Collaborations
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 29 Dec 2022
FDA Grants Appeal for Ardelyx's XPHOZAH(R) (tenapanor)
Biopharmaceuticals Cardiology FDA

HSMN NewsFeed - 27 Dec 2022
Koya Medical Announces the Addition of Chief Medical Officer Dr. Thomas Maldonado to Their Executive Leadership Team
Devices Personnel

HSMN NewsFeed - 27 Dec 2022
BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn(R)
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 20 Dec 2022
SURGLASSES received FDA 510(k) Clearance for Caduceus S
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 19 Dec 2022
Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Cord Stimulation System for Chronic Pain
Devices FDA Product Launch

HSMN NewsFeed - 15 Dec 2022
Providence Medical Technology announces FDA Clearance of the CAVUX(R) Facet Fixation System for the treatment of Cervical Pseudarthrosis
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 9 Dec 2022
Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 7 Dec 2022
Apogee Therapeutics Launches with $169 Million to Develop Potentially Best-in-Class Therapies for Immunological and Inflammatory Disorders
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 5 Dec 2022
Deep Blue Medical Advances Announces FDA Clearance for Sublay Application in Hernia Surgery, Enabling Broader Use of T-Line Hernia Mesh
Devices Surgery FDA

HSMN NewsFeed - 29 Nov 2022
Boston Scientific Announces Agreement to Acquire Apollo Endosurgery, Inc.
Devices Surgery Mergers & Acquisitions

HSMN NewsFeed - 23 Nov 2022
BioMarin Announces Advancements in FDA Review of ROCTAVIAN(TM) (Valoctocogene Roxaparvovec) for Adults with Severe Hemophilia A
Biopharmaceuticals FDA

HSMN NewsFeed - 22 Nov 2022
U.S. Food and Drug Administration Approves CSL's Hemgenix(R) eEtranacogene dezaparvovec-drlb), the First Gene Therapy for Hemophilia B
Biopharmaceuticals FDA

HSMN NewsFeed - 21 Nov 2022
Zimmer Biomet Expands Persona(R) Knee System Portfolio with FDA Clearance of Persona(R) OsseoTi(R) Keel Tibia for Cementless Knee Replacement
Devices Orthopaedic FDA

HSMN NewsFeed - 18 Nov 2022
Synaptogenix Announces $15 Million Private Placement with Existing Investors
Biopharmaceuticals Regenerative Medicine Venture Capital

HSMN NewsFeed - 10 Nov 2022
BrainStorm Cell Therapeutics Receives Refusal to File Letter from FDA for its New Biologics License Application for NurOwn for the treatment of ALS
Biopharmaceuticals Regenerative Medicine Neurology FDA

HSMN NewsFeed - 8 Nov 2022
IceCure's ProSense(R) Achieves Significant Milestone in Medicare Coverage of Breast Cancer Procedures
Devices Reimbursement

HSMN NewsFeed - 3 Nov 2022
Grifols Receives FDA Clearance for Alphaid(TM) At Home, the First Free Service for U.S. Consumers to Determine Their Risk for Alpha-1
Diagnostics FDA

HSMN NewsFeed - 31 Oct 2022
Actinium Announces Positive Top-line Results from Pivotal Phase 3 SIERRA Trial of Iomab-B in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia
Biopharmaceuticals Oncology

HSMN NewsFeed - 21 Oct 2022
Regeneron Receives Six Months of U.S. Pediatric Exclusivity for EYLEA(R) (aflibercept) Injection
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 20 Oct 2022
DePuy Synthes Receives FDA Clearance for TELIGEN(TM) System
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 18 Oct 2022
FDA Approves First IND of its Kind for Allogenic Exosomal Treatment of Female Reproductive Disorder - Primary Ovarian Insufficiency
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Oct 2022
Medtronic First to Receive FDA Approval for Pacing the Heart's Natural Conduction System
Devices Cardiology FDA

HSMN NewsFeed - 17 Oct 2022
Milestone Pharmaceuticals Announces Positive Results from Phase 3 RAPID Clinical Trial of Etripamil Nasal Spray in Patients with Paroxysmal Supraventricular Tachycardia
Biopharmaceuticals Cardiology

HSMN NewsFeed - 10 Oct 2022
Phagenesis Launches Phagenyx Neurostimulation System in the U.S.
Devices Neurology Product Launch

HSMN NewsFeed - 28 Sep 2022
Harrow Announces U.S. FDA Approval of IHEEZO(TM) (Chloroprocaine Hydrochloride Ophthalmic Gel) 3% for Ocular Surface Anesthesia
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 26 Sep 2022
Innocoll and DURECT Announce U.S. launch of POSIMIR(R)
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 22 Sep 2022
FDA Grants QT Imaging(TM) Clearance to Calculate Fibroglandular Volume of the Breast
Devices Oncology FDA

HSMN NewsFeed - 21 Sep 2022
Immunitas Therapeutics Receives FDA Clearance of IND Application for IMT-009 in Solid Tumors and Hematological Malignancies
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 20 Sep 2022
Medtronic receives FDA clearance for expanded indication of LINQ II(TM) insertable cardiac monitor for use in pediatric patients ages 2 and older
Devices Cardiology Monitoring FDA

HSMN NewsFeed - 20 Sep 2022
Zimmer Biomet Receives FDA Clearance for Identity(TM) Shoulder System for Shoulder Replacement
Devices Orthopaedic FDA

HSMN NewsFeed - 16 Sep 2022
Marengo Therapeutics Advances First-In-Class Selective T cell Activator, STAR0602, into Human Trials in Solid Tumors and Enters Cooperative Research and Development Agreement with the National Cancer Institute
Biopharmaceuticals Oncology

HSMN NewsFeed - 15 Sep 2022
BrainStorm Cell Therapeutics Announces Peer Reviewed Publication of Results from the NurOwn(R) Phase 2 Progressive MS Trial in Multiple Sclerosis Journal
Regenerative Medicine Neurology

HSMN NewsFeed - 6 Sep 2022
Boston Scientific Receives FDA Approval for Expanded Labeling of WATCHMAN FLX(TM) LAAC Device for Dual Anti-Platelet Therapy as Post-Procedural Medication Option
Devices Interventional Cardiology FDA

HSMN NewsFeed - 30 Aug 2022
Medtronic completes acquisition of Affera
Devices Cardiology Mergers & Acquisitions

HSMN NewsFeed - 30 Aug 2022
Rafa Receives FDA Approval For Life-saving Midazolam Autoinjector
Biopharmaceuticals Drug Delivery FDA

HSMN NewsFeed - 26 Aug 2022
Inhibikase Therapeutics Announces FDA Clearance of Investigational New Drug Application for IkT-001Pro for the Treatment of Chronic Myelogenous Leukemia
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Aug 2022
Calyptus Pharmaceuticals Announces FDA Approval of Cetrorelix Acetate for Injection, 0.25 mg/vial
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 19 Aug 2022
Verismo Therapeutics Announces Submission of IND Application to the FDA for SynKIR-110TM, a KIR-CAR T-cell Immunotherapy Candidate
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 18 Aug 2022
U.S. FDA Accepts Astellas' New Drug Application for Fezolinetant
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Aug 2022
Alternative Pathway Blocker Anti-Bb Antibody (NM8074) Receives US FDA Clearance to Start Efficacy Trial in C3 Glomerulopathy (C3G) Patients
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Aug 2022
Boston Scientific Announces Acquisition of Obsidio, Inc.
Devices Interventional Mergers & Acquisitions

HSMN NewsFeed - 9 Aug 2022
CereVasc Announces FDA Approval of Second IDE Study of the eShunt(R) System
Devices Neurosurgery Interventional FDA

HSMN NewsFeed - 4 Aug 2022
Amgen to Acquire Chemocentryx for $4 Billion in Cash
Biopharmaceuticals Mergers & Acquisitions

HSMN NewsFeed - 1 Aug 2022
Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections
Biopharmaceuticals FDA

HSMN NewsFeed - 26 Jul 2022
Clinical Study Validates NuVasive Porous Interbody Implant and Synthetic Bone Graft Substitute as Cost-effective Solution for Lateral Lumbar Interbody Fusions
Devices Orthopaedic Neurosurgery

HSMN NewsFeed - 21 Jul 2022
Karyopharm and Menarini Group Receive Full Marketing Authorisation from the European Commission for NEXPOVIO(R) (selinexor) for the Treatment of Patients with Multiple Myeloma After at Least One Prior Therapy
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 14 Jul 2022
Medtronic receives FDA clearance for next-generation UNiD(TM) Spine Analyzer with degenerative spine surgery predictive model
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 11 Jul 2022
Anthos Therapeutics Announces that Abelacimab has Received FDA Fast Track Designation for the Treatment of Thrombosis Associated with Cancer
Biopharmaceuticals FDA

HSMN NewsFeed - 8 Jul 2022
Sobi to license loncastuximab tesirine from ADC Therapeutics
Biopharmaceuticals Oncology Licensing

HSMN NewsFeed - 7 Jul 2022
Renovia receives FDA clearance for leva(R) Pelvic Health System as first-line treatment for chronic fecal incontinence
Devices FDA

HSMN NewsFeed - 5 Jul 2022
Former Itamar Medical CEO & President Gilad Glick Joins IceCure Medical as a Strategic Advisor for Global Go-To-Market Operations
Devices Personnel

HSMN NewsFeed - 1 Jul 2022
Livemetric Receives FDA Clearance for its Watch-Like Wearable Blood Pressure Monitoring Technology, a Long-Awaited Revolution in Cuff-Free Hypertension Monitoring
Devices Monitoring FDA

HSMN NewsFeed - 30 Jun 2022
BD Launches Combination Test for COVID-19, Influenza A/B and Respiratory Syncytial Virus
Diagnostics Product Launch

HSMN NewsFeed - 29 Jun 2022
Invictus' Aura Storm Air Purifier Receives FDA 510(k) Class II Medical Device Clearance
Devices FDA

HSMN NewsFeed - 29 Jun 2022
EYLEA(R) (aflibercept) Injection sBLA for Every 16-week Dosing Regimen in Patients with Diabetic Retinopathy Accepted for FDA Review
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Jun 2022
Ceruvia Lifesciences Receives FDA Investigational New Drug Approval for Psilocybin Obsessive-Compulsive Disorder Program Phase 2 Trial
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 23 Jun 2022
CNS Pharmaceuticals Receives Approval from U.S. FDA for Protocol Amendment to Ongoing Potentially Pivotal Global Trial Evaluating Berubicin for the Treatment of GBM
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 17 Jun 2022
Conformal Medical Announces Launch of CONFORM Pivotal Trial
Devices Interventional Cardiology

HSMN NewsFeed - 15 Jun 2022
RADICAVA ORS(R) (edaravone) Now Available in the U.S. for the Treatment of ALS
Biopharmaceuticals Neurology Product Launch

HSMN NewsFeed - 7 Jun 2022
Eight out of Ten Patients Maintained Skin Clearance at One Year in Lilly's Lebrikizumab Atopic Dermatitis Monotherapy Trials
Biopharmaceuticals Dermatology

HSMN NewsFeed - 1 Jun 2022
Codagenix Receives FDA Clearance of Investigational New Drug Application for Live-Attenuated, Intranasal RSV Vaccine Candidate CodaVax(TM)-RSV
Biopharmaceuticals FDA

HSMN NewsFeed - 31 May 2022
Abbott's FreeStyle Libre(R) 3 Receives U.S. FDA Clearance - Features World's Smallest, Thinnest and Most Accurate 14-Day Glucose Sensor
Devices Endocrinology Monitoring FDA

HSMN NewsFeed - 27 May 2022
Accord Healthcare Adds Pemetrexed Lyo. Injection to Generic Drug Portfolio
Biopharmaceuticals Generics Oncology Product Launch

HSMN NewsFeed - 24 May 2022
Fifty Percent of Patients with Ulcerative Colitis Treated with Mirikizumab Achieved Clinical Remission at One Year in Lilly's Pivotal Phase 3 Study
Biopharmaceuticals Gastroenterology

HSMN NewsFeed - 23 May 2022
Insmed Names Drayton Wise Chief Commercial Officer
Biopharmaceuticals Personnel

HSMN NewsFeed - 13 May 2022
Medtronic receives FDA approval for latest generation drug-eluting coronary stent system
Devices Interventional Cardiology FDA

HSMN NewsFeed - 12 May 2022
BD Launches Fully Automated, High-Throughput Infectious Disease Molecular Diagnostic Platform in the U.S.
Diagnostics FDA Product Launch

HSMN NewsFeed - 9 May 2022
Marengo Therapeutics Appoints Ke Liu, MD, PhD, and Bruce Chabner, MD, to Key Leadership Roles, Strengthening Marengo's Development Team and Supporting Translation to the Clinic
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 2 May 2022
Supernus Announces FDA Approval of Qelbree(R) for the Treatment of ADHD in Adults
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 26 Apr 2022
Halozyme Commences Tender Offer for All Outstanding Shares of Common Stock of Antares Pharma
Biopharmaceuticals Drug Delivery Mergers & Acquisitions

HSMN NewsFeed - 21 Apr 2022
NuVasive Simplify Cervical Disc Two-level Data Published in Journal of Neurosurgery: Spine
Devices Orthopaedic Neurosurgery

HSMN NewsFeed - 20 Apr 2022
ZEISS Announces U.S. FDA Clearance of the QUATERA 700, a Revolution in Phaco Technology
Devices Ophthalmology FDA

HSMN NewsFeed - 19 Apr 2022
Regeneron to Acquire Checkmate Pharmaceuticals and Its Investigational Immune Activator for Potential Use in Multiple Tumor Types
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 18 Apr 2022
BENDIT Technologies Receives U.S. Food and Drug Administration 510(k) Clearance of its Bendit 021" Steerable Microcatheter
Devices Interventional FDA

HSMN NewsFeed - 15 Apr 2022
SonoScape receives FDA 510(k) clearance for HD-550 Endoscopy system
Devices Gastroenterology FDA

HSMN NewsFeed - 13 Apr 2022
Halozyme to Acquire Antares Pharma to Create a Specialty Product and Drug Delivery Leader
Biopharmaceuticals Drug Delivery Mergers & Acquisitions

HSMN NewsFeed - 7 Apr 2022
Jazz Pharmaceuticals and Werewolf Therapeutics Announce Exclusive Global License and Collaboration Agreement to Develop WTX-613, a Differentiated, Conditionally-Activated IFNα INDUKINE(TM) Molecule
Biopharmaceuticals Licensing

HSMN NewsFeed - 6 Apr 2022
FDA approves Novartis Vijoice(R) (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Apr 2022
Allergan, an AbbVie Company, Announces Positive Topline Phase 3 Results Evaluating Investigational Twice-Daily Administration of VUITY(TM) (pilocarpine HCI ophthalmic solution) 1.25% in Adults with Age-Related Blurry Near Vision (Presbyopia)
Biopharmaceuticals Ophthalmology

HSMN NewsFeed - 4 Apr 2022
FDA approves Nobelpharma's HYFTOR(TM) (sirolimus topical gel) 0.2%
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Mar 2022
FDA approves CartiHeal's Implant for the Treatment of Cartilage and Osteochondral Defects
Devices Orthopaedic FDA

HSMN NewsFeed - 28 Mar 2022
Jazz Pharmaceuticals Announces Agreement to Divest Sunosi(R) (solriamfetol) to Axsome Therapeutics
Biopharmaceuticals Neurology Acquisitions

HSMN NewsFeed - 25 Mar 2022
Sky Medical Technology wins further FDA clearance to market the new (W3) geko(TM) device variant for venous insufficiency and ischemia
Devices FDA

HSMN NewsFeed - 24 Mar 2022
HLT, Inc. Gains FDA Approval for Two TAVR Clinical Studies
Devices Interventional Cardiology FDA

HSMN NewsFeed - 21 Mar 2022
NeuroSense Therapeutics Receives FDA Clearance of IND for PrimeC for the Treatment of ALS
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 18 Mar 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of the BRIGHT Phase III Clinical Trial Evaluating PRX-102 for the Treatment of Fabry Disease
Biopharmaceuticals

HSMN NewsFeed - 17 Mar 2022
Heron Therapeutics Announces Approval of ZYNRELEF(R) by Health Canada for the Management of Postoperative Pain
Biopharmaceuticals Drug Delivery Regulatory

HSMN NewsFeed - 14 Mar 2022
Dialectic Therapeutics Announces DT2216 Has Received Orphan Drug Designation from the FDA for the Treatment of T-Cell Lymphoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 10 Mar 2022
S.M.A.R.T. RADIANZ(TM) Vascular Stent System Approved for Transradial Use in the U.S.
Devices Interventional FDA

HSMN NewsFeed - 3 Mar 2022
Inhibrx Receives FDA Orphan-Drug Designation for INBRX-101 for the Treatment of Alpha-1 Antitrypsin Deficiency
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Mar 2022
Valencia Technologies Announces FDA Approval of eCoin(R) Therapy to Treat Urinary Urge Incontinence
Devices Urology FDA

HSMN NewsFeed - 1 Mar 2022
Zimmer Biomet Announces Completion of ZimVie Spinoff
Devices Orthopaedic Dental

HSMN NewsFeed - 28 Feb 2022
Medtronic Announces Launch of NuVent(TM) Eustachian Tube Dilation Balloon
Devices Interventional Product Launch

HSMN NewsFeed - 28 Feb 2022
After Successful Launch of Titan SGS(R) Surgical Stapler, Standard Bariatrics, Inc. Achieves Final Series B Funding Early
Devices Surgery Venture Capital

HSMN NewsFeed - 24 Feb 2022
Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce the Submission of a Marketing Authorization Application to the European Medicines Agency for PRX-102 for the Treatment of Fabry Disease
Biopharmaceuticals Regulatory

HSMN NewsFeed - 21 Feb 2022
Abbott's CardioMEMS(TM) HF System Receives FDA Approval to Support Patients Battling Earlier-Stage Heart Failure
Devices Monitoring Cardiology FDA

HSMN NewsFeed - 15 Feb 2022
Cardiosense Receives FDA Breakthrough Device Designation for Algorithm to Identify Patients at Risk of Decompensated Heart Failure
Devices Cardiology FDA

HSMN NewsFeed - 14 Feb 2022
Biohaven and Pfizer Announce Positive Topline Results of Pivotal Trial of Rimegepant for the Acute Treatment of Migraine in China and South Korea
Biopharmaceuticals Neurology

HSMN NewsFeed - 8 Feb 2022
CereVasc Receives FDA IDE Approval to Begin Initial Clinical Study of the eShunt(R) System for Patients with Normal Pressure Hydrocephalus
Devices Interventional Neurosurgery FDA

HSMN NewsFeed - 8 Feb 2022
Gala Therapeutics Announces First Commercial Cases Worldwide with RheOx(R) System for Chronic Bronchitis
Devices

HSMN NewsFeed - 7 Feb 2022
Check-Cap Announces FDA Approval of Amended IDE Application for Pivotal Study of C-Scan
Devices Gastroenterology Oncology FDA

HSMN NewsFeed - 7 Feb 2022
Zimmer Biomet Announces Expected Completion Date of March 1, 2022 for Spinoff of ZimVie
Devices Orthopaedic Dental Mergers & Acquisitions

HSMN NewsFeed - 28 Jan 2022
FDA Accepts Label Update for Plasma IQ(TM), the First FDA-Cleared Handheld Plasma Energy Device
Devices Dermatology FDA

HSMN NewsFeed - 28 Jan 2022
Blueprint Medicines' AYVAKYT(R) (avapritinib) Receives Positive CHMP Opinion for the Treatment of Adults with Advanced Systemic Mastocytosis
Biopharmaceuticals Oncology Regulatory

HSMN NewsFeed - 24 Jan 2022
Smith & Nephew's PICO(TM) 7 and PICO 14 Negative Pressure Wound Therapy Systems are the first systems indicated to aid in reducing the incidence of both deep and superficial incisional surgical site infections and dehiscence
Devices Wound Care

HSMN NewsFeed - 19 Jan 2022
Titan SGS(R) from Standard Bariatrics, Inc. Passes 1,000 Clinical Case Uses
Devices Surgery

HSMN NewsFeed - 18 Jan 2022
Endomina(R) System, a New Suturing Tool for Use by Gastroenterologists Receives FDA Clearance
Devices Gastroenterology FDA

HSMN NewsFeed - 14 Jan 2022
Vanda Pharmaceuticals Settles HETLIOZ(R) Patent Litigation with MSN
Biopharmaceuticals Generics Litigation Licensing

HSMN NewsFeed - 13 Jan 2022
SK Life Science Announces FDA Clearance of IND Application for its Oncology Candidate, SKL27969, a PRMT5 Inhibitor for the Potential Treatment of Advanced Solid Tumors
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 Jan 2022
Abbott Receives U.S. FDA Clearance for New Cardiac Mapping System to Improve How Doctors Treat Abnormal Heart Rhythms
Devices Interventional Cardiology FDA

HSMN NewsFeed - 6 Jan 2022
BlueWind Medical(TM) Ltd. Makes Key Additions to Leadership Team
Devices Urology Personnel

HSMN NewsFeed - 5 Jan 2022
Meridian Bioscience Receives FDA Clearance for the Curian(R) Campy Assay
Diagnostics FDA

HSMN NewsFeed - 4 Jan 2022
Abbott's Proclaim(TM) XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S.
Devices Neurology Radiology FDA

HSMN NewsFeed - 3 Jan 2022
Zynex Submits FDA Application for its Next Generation Fluid and Blood Volume Monitor
Devices Monitoring FDA

HSMN NewsFeed - 3 Jan 2022
Curis Adds Three New Executives to Management Team Strengthening Medical Affairs, Clinical Development and Clinical Operations
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 30 Dec 2021
Blueprint Medicines Completes Acquisition of Lengo Therapeutics
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 27 Dec 2021
Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1(TM) Implant System
Devices Dental FDA

HSMN NewsFeed - 27 Dec 2021
FDA Authorizes Further NurOwn(R) Dosing Under Expanded Access Program
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 21 Dec 2021
Lilly's lebrikizumab demonstrated significant skin improvement and itch relief when combined with topical corticosteroids in people with atopic dermatitis in third Phase 3 study
Biopharmaceuticals Dermatology

HSMN NewsFeed - 15 Dec 2021
FDA Approves First Drug to Prevent Graft Versus Host Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Dec 2021
Medtronic Diabetes Receives FDA Warning Letter
Devices Drug Delivery Endocrinology FDA

HSMN NewsFeed - 14 Dec 2021
Medtronic INVOS(TM) 7100 Cerebral/Somatic Oximetry System receives 510(k) clearance for pediatric indications
Devices Monitoring FDA

HSMN NewsFeed - 8 Dec 2021
Nuvation Bio Announces FDA Clearance of Investigational New Drug Application for NUV-422 for the Treatment of Advanced Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 6 Dec 2021
Sapience Therapeutics Receives FDA Fast Track Designation for ST101 for the Treatment of Recurrent Glioblastoma Multiforme (GBM)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Nov 2021
FDA Authorizes PrecisionOS to Market VR Surgical Planning Tool
Devices Surgery FDA

HSMN NewsFeed - 29 Nov 2021
Viracta Therapeutics Announces Orphan Drug Designation Granted by FDA for its All-Oral Combination of Nanatinostat and Valganciclovir (Nana-val) for the Treatment of Epstein Barr Virus-Positive Diffuse Large B-cell Lymphoma
Biopharmaceuticals FDA

HSMN NewsFeed - 29 Nov 2021
Blueprint Medicines to Expand Precision Therapy Leadership in Lung Cancer with Acquisition of Lengo Therapeutics
Biopharmaceuticals Oncology Mergers & Acquisitions

HSMN NewsFeed - 19 Nov 2021
BioMarin Receives FDA Approval for VOXZOGO(TM) (vosoritide) for Injection, Indicated to Increase Linear Growth in Children with Achondroplasia Aged 5 and Up with Open Growth Plates
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Nov 2021
NURTEC(R) ODT Approved In Kuwait For Acute Treatment Of Migraine
Biopharmaceuticals Regulatory

HSMN NewsFeed - 16 Nov 2021
Geneoscopy Closes $105M in Financing to Advance its Noninvasive Multifactor RNA Screening Test for Colorectal Cancer Prevention
Diagnostics Venture Capital

HSMN NewsFeed - 16 Nov 2021
Sofwave(TM) Announces FDA clearance of New Lifting Indications for Eyebrow, Sub-Mental (beneath the chin) and Neck Facial Areas
Devices Dermatology FDA

HSMN NewsFeed - 8 Nov 2021
BrainStorm Cell Therapeutics Expands Leadership Team to Support Clinical Development and Medical Affairs
Biopharmaceuticals Neurology Personnel

HSMN NewsFeed - 8 Nov 2021
Azurity Pharmaceuticals, Inc. Announces FDA Approval of Eprontia(TM) (Topiramate) Oral Solution
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 3 Nov 2021
Insightec Announces FDA Approval of Exablate Neuro for the Treatment of Parkinson's Disease
Devices Neurology FDA

HSMN NewsFeed - 1 Nov 2021
Theseus Pharmaceuticals Announces FDA Clearance of Investigational New Drug Application for THE-630, a Pan-Variant KIT Inhibitor in Development for the Treatment of Gastrointestinal Stromal Tumors (GIST)
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 27 Oct 2021
HT Supreme(R) Drug Eluting Stent performs equivalent to best-in-class in the PIONEER III publication
Devices Interventional Cardiology

HSMN NewsFeed - 20 Oct 2021
FDA Expands Approval of Dupixent(R) (dupilumab) to Include Children Aged 6 to 11 Years with Moderate-to-severe Asthma
Biopharmaceuticals FDA

HSMN NewsFeed - 18 Oct 2021
FDA Approves Cyltezo, the First Interchangeable Biosimilar to Humira
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 18 Oct 2021
Oyster Point Pharma Announces FDA Approval of TYRVAYA(TM) (varenicline solution) Nasal Spray for the Treatment of the Signs and Symptoms of Dry Eye Disease
Biopharmaceuticals Ophthalmology FDA

HSMN NewsFeed - 13 Oct 2021
Varian Receives FDA "Breakthrough Device Designation" For Embozene(R) Microspheres For Genicular Artery Embolization For Symptomatic Knee Osteoarthritis
Devices Interventional FDA

HSMN NewsFeed - 13 Oct 2021
FDA Approves Verzenio(R) (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 8 Oct 2021
Alpha Tau Receives FDA's Breakthrough Device Designation for the Treatment of Recurrent GBM
Devices Oncology FDA

HSMN NewsFeed - 6 Oct 2021
Boston Scientific Announces Agreement to Acquire Baylis Medical Company Inc.
Devices Cardiology Mergers & Acquisitions

HSMN NewsFeed - 6 Oct 2021
BD Announces 510(k) Clearance of Expanded Indications for the Rotarex(TM) Atherectomy System
Devices Interventional FDA

HSMN NewsFeed - 1 Oct 2021
Breckenridge Announces Launch of its 10mg strength for Everolimus Tablets (generic for Afinitor(R))
Biopharmaceuticals Generics Product Launch

HSMN NewsFeed - 30 Sep 2021
OLUMIANT(R) Significantly Improved Hair Regrowth to At Least 80% Scalp Coverage as Early as 24 Weeks Across First Completed Phase 3 Studies for Alopecia Areata
Biopharmaceuticals

HSMN NewsFeed - 29 Sep 2021
TransMedics Receives FDA Approval for its OCS Liver System for Preservation and Assessment of Donor Livers for Transplantation
Devices FDA

HSMN NewsFeed - 27 Sep 2021
Ortho Clinical Diagnostics Announces Launch of New ISXM Capabilities
Diagnostics Product Launch

HSMN NewsFeed - 22 Sep 2021
Kleiner Device Labs Receives FDA Market Clearance for KG2 Surge Flow-Thru Interbody System
Devices Neurosurgery Orthopaedic FDA

HSMN NewsFeed - 21 Sep 2021
FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis
Biopharmaceuticals Dermatology FDA

HSMN NewsFeed - 20 Sep 2021
Mirati Therapeutics Appoints David Meek as Chief Executive Officer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 19 Sep 2021
Pfizer Expands Voluntary Nationwide Recall to include Four Additional Lots of CHANTIX(R) (varenicline) Tablets Due to N- Nitroso Varenicline Content
Biopharmaceuticals FDA Product Recall

HSMN NewsFeed - 16 Sep 2021
LUMAKRAS(TM) (Sotorasib) Combined With Vectibix(R) (Panitumumab) Showed Encouraging Efficacy And Safety In Patients With KRAS G12C-Mutated Colorectal Cancer
Biopharmaceuticals Oncology

HSMN NewsFeed - 7 Sep 2021
RenovoRx Receives New 510(k) Clearance for its RenovoCath(R) Delivery System Designed for Targeted Treatment of Solid Tumors
Devices Drug Delivery Oncology FDA

HSMN NewsFeed - 6 Sep 2021
U.S. FDA Placed a Clinical Hold on BMN 307 Phearless Phase 1/2 Gene Therapy Study in Adults with PKU Based on Interim Pre-clinical Study Findings
Biopharmaceuticals FDA

HSMN NewsFeed - 2 Sep 2021
Abbott Expands Peripheral Vascular Offerings with Acquisition of Walk Vascular, LLC
Devices Interventional Mergers & Acquisitions

HSMN NewsFeed - 1 Sep 2021
Tyber Medical Receives Largest FDA 510(k) Clearance For Expanded Line Of Anatomical Plating Systems
Devices Orthopaedic FDA

HSMN NewsFeed - 30 Aug 2021
Poseida Therapeutics Announces FDA Clearance of Investigational New Drug Application for P-BCMA-ALLO1, an Allogeneic CAR-T Candidate for Relapsed/Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Aug 2021
Zimmer Biomet and Canary Medical Announce FDA De Novo Classification Grant and Authorization to Market the World's First and Only Smart Knee Implant
Devices Orthopaedic FDA

HSMN NewsFeed - 27 Aug 2021
European Commission Approves BioMarin's VOXZOGO(R) (vosoritide) for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory

HSMN NewsFeed - 25 Aug 2021
BD Launches Fully Automated High-Throughput Molecular Diagnostic Platform for U.S. Laboratories
Diagnostics Product Launch

HSMN NewsFeed - 24 Aug 2021
European Commission Approves RINVOQ(R) (upadacitinib) as First JAK Inhibitor in the European Union for the Treatment of Both Adults and Adolescents with Moderate to Severe Atopic Dermatitis
Biopharmaceuticals Dermatology Regulatory

HSMN NewsFeed - 24 Aug 2021
InDex Pharmaceuticals receives FDA clearance to start the phase III study CONCLUDE with cobitolimod
Biopharmaceuticals Gastroenterology FDA

HSMN NewsFeed - 18 Aug 2021
Zimmer Biomet Receives FDA Clearance for ROSA(R) Hip System for Robotically-Assisted Direct Anterior Total Hip Arthroplasty
Devices Orthopaedic FDA

HSMN NewsFeed - 16 Aug 2021
Abbott's Amplatzer(TM) Amulet(TM) Device Approved by FDA to Treat People With Atrial Fibrillation at Risk of Stroke
Devices Interventional Cardiology FDA

HSMN NewsFeed - 16 Aug 2021
Lilly's lebrikizumab significantly improved skin clearance and itch in people with moderate-to-severe atopic dermatitis in two Phase 3 trials
Biopharmaceuticals Dermatology

HSMN NewsFeed - 16 Aug 2021
Occlutech granted important conditional FDA approval for PFO Study (OCCLUFLEX) in the U.S.
Devices Interventional Cardiology FDA

HSMN NewsFeed - 13 Aug 2021
Rigel Pharmaceuticals Provides Update on COVID-19 Program
Biopharmaceuticals

HSMN NewsFeed - 12 Aug 2021
Second U.S. FDA Breakthrough Device Designation Granted to CytoSorbents' DrugSorb-ATR(TM) Antithrombotic Removal System Adding the Removal of Market-Leading Direct Oral Anticoagulants During Urgent Cardiothoracic Surgery
Devices FDA

HSMN NewsFeed - 11 Aug 2021
FDA Grants Lantern Pharma Orphan Drug Designation for Drug Candidate LP-184 in the Treatment of Pancreatic Cancer
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 9 Aug 2021
SKYRIZI(R) (risankizumab-rzaa) Now Available in the U.S. as a Single 150 mg Injection for Adults with Moderate to Severe Plaque Psoriasis
Biopharmaceuticals Dermatology Product Launch

HSMN NewsFeed - 6 Aug 2021
FDA Approves New Treatment for Pompe Disease
Biopharmaceuticals FDA

HSMN NewsFeed - 5 Aug 2021
Breckenridge Announces Final Approval of its ANDA for Apixaban Tablets (generic for Eliquis(R))
Biopharmaceuticals Generics FDA

HSMN NewsFeed - 3 Aug 2021
Lilly and Incyte's baricitinib reduced deaths among patients with COVID-19 receiving invasive mechanical ventilation
Biopharmaceuticals

HSMN NewsFeed - 2 Aug 2021
Abbott's FreeStyle(R) Libre 2 iOS App Cleared in U.S., Providing a Seamless Digital Experience to Simplify Diabetes Management
Devices Monitoring Endocrinology FDA

HSMN NewsFeed - 2 Aug 2021
Alkermes Receives FDA Fast Track Designation for Nemvaleukin Alfa for the Treatment of Mucosal Melanoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 30 Jul 2021
NuVasive Receives Latest FDA 510(k) Clearance for Pulse Platform and Announces Commercial Launch
Devices Neurosurgery Orthopaedic FDA Product Launch

HSMN NewsFeed - 29 Jul 2021
BD to Begin Remediation for BD Alaris(TM) System Software
Devices Product Recall

HSMN NewsFeed - 28 Jul 2021
Medtronic Announces FDA Clearance and Results of Artificial Intelligence Algorithms for Cardiac Monitoring
Devices Cardiology FDA

HSMN NewsFeed - 21 Jul 2021
Corium Launches Innovative ADHD Treatment AZSTARYS(TM) (serdexmethylphenidate and dexmethylphenidate) in the U.S. for Patients Age 6 Years and Older
Biopharmaceutical Neurology Product Launch

HSMN NewsFeed - 21 Jul 2021
PathogenDx Receives CE-IVD Mark for Its Microarray-Based DetectX-Rv Test for COVID-19
Diagnostics Regulatory

HSMN NewsFeed - 20 Jul 2021
Alma, a Sisram Medical Company, Announces FDA Clearance and the U.S. Launch of Alma Hybrid(TM)
Devices Dermatology FDA Product Launch

HSMN NewsFeed - 19 Jul 2021
BlueRock Therapeutics Receives FDA Fast Track Designation for DA01 in the Treatment of Advanced Parkinson's Disease
Regenerative Medicine Neurology FDA

HSMN NewsFeed - 15 Jul 2021
iSTAR Medical receives U.S. FDA approval to start pivotal trial for MINIject in glaucoma patients
Devices Ophthalmology FDA

HSMN NewsFeed - 12 Jul 2021
Janssen Announces U.S. FDA Approval of DARZALEX FASPRO(R) (daratumumab and hyaluronidase-fihj) in Combination with Pomalidomide and Dexamethasone for Patients with Multiple Myeloma After First or Subsequent Relapse
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 12 Jul 2021
FDA Approves Expanded Sterilization and Disinfectant Methods for the LUMINELLE(R) DTx System
Devices FDA

HSMN NewsFeed - 7 Jul 2021
Hyalex Orthopaedics receives FDA Breakthrough Device Designation for novel HYALEX(R) Cartilage System
Devices Orthopaedic FDA

HSMN NewsFeed - 1 Jul 2021
Heron Therapeutics Announces U.S. Commercial Launch and Availability of ZYNRELEF(TM) for the Management of Postoperative Pain for up to 72 Hours
Biopharmaceuticals Drug Delivery Product Launch

HSMN NewsFeed - 30 Jun 2021
Mitsubishi Tanabe Pharma America Announces EXSERVAN(TM) (riluzole) is Now Available in the U.S. for the Treatment of ALS
Biopharmaceuticals Neurology Product Launch

HSMN NewsFeed - 30 Jun 2021
Abbott's XIENCE Stent Receives FDA Approval for Shortest Blood Thinner Course for High Bleeding Risk Patients
Devices Interventional Cardiology FDA

HSMN NewsFeed - 29 Jun 2021
FDA Grants Fast Track Designation to CNS Pharmaceuticals for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 25 Jun 2021
Jazz Pharmaceuticals Announces Orphan Drug Exclusivity for Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution
Biopharmaceuticals FDA

HSMN NewsFeed - 25 Jun 2021
BioMarin Receives Positive CHMP Opinion in Europe for Vosoritide for the Treatment of Children with Achondroplasia from Age 2 Until Growth Plates Close
Biopharmaceuticals Regulatory

HSMN NewsFeed - 24 Jun 2021
Lilly's donanemab receives U.S. FDA's Breakthrough Therapy designation for treatment of Alzheimer's disease
Biopharmaceuticals Neurology FDA

HSMN NewsFeed - 23 Jun 2021
Evrysdi(TM) Approved in Japan for the Treatment of Spinal Muscular Atrophy
Biopharmaceuticals Regulatory

HSMN NewsFeed - 23 Jun 2021
BD Announces Expanded 510(k) Clearance for At-Home System for Ascites
Devices FDA

HSMN NewsFeed - 17 Jun 2021
Irrimax Receives FDA Clearance for Irrisept(R) as an Antimicrobial Wound Lavage for US Market
Biopharmaceuticals FDA

HSMN NewsFeed - 17 Jun 2021
Elekta radiotherapy system designed for changing cancer landscape now available for U.S. patients
Devices Oncology FDA

HSMN NewsFeed - 16 Jun 2021
Spark(TM) Aligners Receive FDA Clearance For Orthodontic Treatment Of Kids, Giving Parents A New Option With Significant Treatment Advantages Over The Leading Competitor
Devices Dental FDA

HSMN NewsFeed - 16 Jun 2021
Veralox Therapeutics Announces Closing Of $16.6 Million Series A Financing And Announces New Board Members
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 14 Jun 2021
FDA Clears LPCN 1154 IND Application for a Phase 2 Postpartum Depression Study
Biopharmaceuticals FDA

HSMN NewsFeed - 10 Jun 2021
Nuvo Group Receives 510(k) FDA Clearance for Remote Monitoring of Uterine Activity
Devices Monitoring FDA

HSMN NewsFeed - 10 Jun 2021
Cardinal Health(TM) Nuclear & Precision Health Solutions Receives U.S. Food and Drug Administration Approval for New LYMPHOSEEK(R) Pediatric Indication
Biopharmaceuticals Radiology Oncology FDA

HSMN NewsFeed - 7 Jun 2021
FDA Approves First-of-its-Kind SenSight(TM) Directional Lead System for DBS Therapy
Devices Neurology FDA

HSMN NewsFeed - 4 Jun 2021
Ortho Regenerative Technologies Receives Clinical Hold Letter From the U.S. FDA
Regenerative Medicine Orthopaedic FDA

HSMN NewsFeed - 3 Jun 2021
Medtronic Gains FDA Clearance of UNiD(TM) Patient-Specific Rods for Use with CD Horizon(TM) Solera(TM) Voyager(TM) and Infinity(TM) OCT Spinal Systems
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 3 Jun 2021
Medtronic to Stop Distribution and Sale of HVAD(TM) System
Devices Cardiology Distribution

HSMN NewsFeed - 1 Jun 2021
Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for Teclistamab for the Treatment of Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Jun 2021
Amgen and Kyowa Kirin to Jointly Develop and Commercialize KHK4083, a Phase 3-Ready, Potential First-In-Class Treatment for Atopic Dermatitis
Biopharmaceuticals Dermatology

HSMN NewsFeed - 27 May 2021
FDA Grants Micro Interventional Devices, Inc. Breakthrough Device Designation for the MIA(TM)-T Percutaneous Tricuspid Annuloplasty System
Devices Interventional Cardiology FDA

HSMN NewsFeed - 26 May 2021
Varian Receives FDA "Breakthrough Device Designation" for its Cardiac Radioablation (CRA) System for Treatment of Refractory Ventricular Tachycardia (VT)
Devices Cardiology FDA

HSMN NewsFeed - 24 May 2021
FDA Clearance of the Uro-G Completes UroViu Corporation's Suite of Portable, Single-Use, Disposable Cystoscopes
Devices Urology FDA

HSMN NewsFeed - 20 May 2021
Gala Therapeutics Announces First Patients Enrolled in Pivotal Trial of RheOx(TM) System for Chronic Bronchitis
Devices

HSMN NewsFeed - 13 May 2021
Heron Therapeutics Announces U.S. FDA Approval of ZYNRELEF(TM) (HTX-011) for the Management of Postoperative Pain for up to 72 Hours
Biopharmaceuticals FDA

HSMN NewsFeed - 10 May 2021
Allergan Aesthetics to Acquire Soliton, Expanding Body Contouring Portfolio
Devices Dermatology Mergers & Acquisitions

HSMN NewsFeed - 3 May 2021
Karyopharm Announces the Appointment of Richard Paulson as President and Chief Executive Officer
Biopharmaceuticals Oncology Personnel

HSMN NewsFeed - 29 Apr 2021
Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease
Devices Orthopaedic Neurosurgery FDA

HSMN NewsFeed - 29 Apr 2021
Soliton Receives FDA Clearance of Special 510(k)
Devices Dermatology FDA

HSMN NewsFeed - 28 Apr 2021
Protalix BioTherapeutics and Chiesi Global Rare Diseases Receive Complete Response Letter for Pegunigalsidase Alfa from FDA
Biopharmaceuticals FDA

HSMN NewsFeed - 27 Apr 2021
Medtronic Receives FDA Breakthrough Designation for the Emprint(TM) Ablation Catheter Kit
Devices FDA

HSMN NewsFeed - 27 Apr 2021
Medtronic Receives FDA Approval to Launch Clinical Study for Implantable Tibial Neuromodulation Therapy for Bladder Incontinence
Devices Urology FDA

HSMN NewsFeed - 26 Apr 2021
BD Announces FDA 510(k) Submission for BD Alaris(TM) System
Devices FDA

HSMN NewsFeed - 22 Apr 2021
Ortho Dermatologics Announces Statistically Significant Topline Results From Second Pivotal Phase 3 Clinical Trial Evaluating IDP-126 Gel In Acne Vulgaris
Biopharmaceuticals Dermatology

HSMN NewsFeed - 21 Apr 2021
Cerus Endovascular Announces IDE Approval from the U.S. FDA to Conduct Clinical Study of the Contour Neurovascular System(TM)
Devices Interventional Neurosurgery FDA

HSMN NewsFeed - 20 Apr 2021
Zimmer Biomet Receives FDA Clearance for ROSA(R) Partial Knee System for Robotically-Assisted Partial Knee Arthroplasty
Devices Orthopaedic FDA

HSMN NewsFeed - 20 Apr 2021
Lilly and Incyte's Baricitinib Improved Hair Regrowth for Alopecia Areata Patients in Second Phase 3 Study
Biopharmaceuticals

HSMN NewsFeed - 19 Apr 2021
Curis Receives FDA Orphan Drug Designation for CA-4948 for the Treatment of AML and MDS
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 19 Apr 2021
Amgen Launches Biomarker Assist(TM), a Program To Help More Patients With Non-Small Cell Lung Cancer Gain Access To Biomarker Testing
Diagnostics Oncology Product Launch

HSMN NewsFeed - 16 Apr 2021
Lilly requests revocation of emergency use authorization for bamlanivimab alone to complete transition to bamlanivimab and etesevimab together for treatment of COVID-19 in the U.S.
Biopharmaceuticals FDA

HSMN NewsFeed - 15 Apr 2021
Vicarious Surgical Inc. and D8 Holdings Corp. Announce Definitive Business Combination Agreement
Devices Surgery Mergers & Acquisitions

HSMN NewsFeed - 13 Apr 2021
Ortho's VITROS(R) SARS-CoV-2 Antigen Test for High-Volume COVID-19 Testing Receives CE Mark; Allows for More Convenient Sample Collection and Expanded Viral Transport Media
Diagnostics Regulatory

HSMN NewsFeed - 12 Apr 2021
Memic Innovative Surgery Raises $96 Million
Devices Surgery Venture Capital

HSMN NewsFeed - 12 Apr 2021
U.S. FDA Grants De Novo Clearance for First and Only Artificial Intelligence System for Colonoscopy; Medtronic Launches GI Genius(TM) Intelligent Endoscopy Module
Devices Gastroenterology FDA Product Launch

HSMN NewsFeed - 9 Apr 2021
Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module for Enhanced Surgical Visualization
Devices Surgery FDA

HSMN NewsFeed - 8 Apr 2021
Crown Aesthetics Proudly Announces New Indication For Treatment Of Neck Wrinkles For FDA-Cleared Microneedling System, SkinPen(R) Precision
Devices Dermatology FDA

HSMN NewsFeed - 8 Apr 2021
Lilly and Incyte announce results from the Phase 3 COV-BARRIER study of baricitinib in hospitalized COVID-19 patients
Biopharmaceuticals

HSMN NewsFeed - 7 Apr 2021
FDA Approves Bausch & Lomb ClearVisc(TM) Dispersive Ophthalmic Viscosurgical Device
Devices Ophthalmology FDA

HSMN NewsFeed - 6 Apr 2021
Mineralys Therapeutics Closes $40 Million Series A Funding
Biopharmaceuticals Cardiology Venture Capital Personnel

HSMN NewsFeed - 5 Apr 2021
IceCure Medical Granted FDA Breakthrough Device Designation for ProSense(R) Cryoablation System
Devices Oncology FDA

HSMN NewsFeed - 5 Apr 2021
Ionis initiates Phase 3 trial of novel antisense medicine to treat leading cause of juvenile-onset ALS
Biopharmaceuticals Neurology

HSMN NewsFeed - 1 Apr 2021
FDA Grants Breakthrough Therapy Designation for Taiho Oncology's Futibatinib for Treatment of Advanced Cholangiocarcinoma
Biopharmaceuticals Oncology FDA

HSMN NewsFeed - 1 Apr 2021
United Therapeutics Announces FDA Approval and Launch of Tyvaso(R) for the Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Biopharmaceuticals FDA Product Launch

HSMN NewsFeed - 31 Mar 2021
CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Biopharmaceuticals FDA

HSMN NewsFeed - 30 Mar 2021
PTC Therapeutics Announces the European Approval of Evrysdi(TM) for the Treatment of Spinal Muscular Atrophy
Biopharmaceuticals Regulatory

HSMN NewsFeed - 26 Mar 2021
Constipation treatment Vibrant raises $7.5 million led by Unorthodox Ventures
Devices Gastroenterology Venture Capital

HSMN NewsFeed - 23 Mar 2021
Emalex Biosciences Raises $35 Million in Series C Preferred Stock to Advance Tourette Syndrome and Stuttering Clinical Trials
Biopharmaceuticals Venture Capital

HSMN NewsFeed - 22 Mar 2021
Medtronic Receives CE Mark Approval for SenSight(TM) Directional Lead System for DBS Therapy
Devices Neurology Regulatory

HSMN NewsFeed - 19 Mar 2021
Oramed Forms a Joint Venture, Oravax Medical Inc., for the Development of Novel Oral COVID-19 Vaccines
Biopharmaceuticals

HSMN NewsFeed - 18 Mar 2021
Boston Scientific Receives FDA Approval for TheraSphere(TM) Y-90 Glass Microspheres
Devices Oncology FDA

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