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Healthcare News Roundup: FDA

 HSMN NewsFeed - 3 Aug 2020
Stryker's Neuroform Atlas(R) Stent System granted an expanded indication, providing a new option for patients with aneurysms in the back of the brain
Devices Interventional Neurology FDA
 HSMN NewsFeed - 3 Aug 2020
FDA Accepts and Grants Priority Review of Vanda's Applications for HETLIOZ(R) (tasimelteon) in the Treatment of Smith-Magenis Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 3 Aug 2020
Lannett Announces Launch Of FDA Approved Levothyroxine Tablets
Biopharmaceuticals Endocrinology Product Launch
 HSMN NewsFeed - 29 Jul 2020
Jay Pharma to File IND Applications to FDA for a clinical study of proprietary formulations in Radiodermatitis and a combination Therapy in Glioblastoma
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 Jul 2020
Truvian Sciences Receives FDA Emergency Use Authorization for Easy Check COVID-19 IgM/IgG(TM) Test
Diagnostics FDA Product Launch
 HSMN NewsFeed - 28 Jul 2020
HemoShear Therapeutics Receives FDA Fast Track and Rare Pediatric Disease Designations for HST5040 to Treat Methylmalonic Acidemia and Propionic Acidemia
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Jul 2020
Stratus(TM) Medical announces FDA 510k clearance for the Vesta(TM) RF Cannula to expand product portfolio and the first Vesta patient treatments in the United States
Devices FDA
 HSMN NewsFeed - 27 Jul 2020
CARISMA Therapeutics Announces FDA Clearance of IND Application for First-Ever Engineered Macrophage Immunotherapy
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Jul 2020
Abbott Receives FDA Approval for iOS-Compatible App Allowing People Living With Chronic Pain and Movement Disorders to Personalize Therapy Via Their Mobile Device
Devices Neurology FDA
 HSMN NewsFeed - 23 Jul 2020
FDA Clears First Blood Test for Identifying a Novel Allergic Sensitization to Red Meat
Diagnostics FDA
 HSMN NewsFeed - 23 Jul 2020
Beckman Coulter's Automated Blood Banking Analyzer Receives 510(k) FDA Clearance
Diagnostics FDA
 HSMN NewsFeed - 22 Jul 2020
Cerapedics Announces FDA approval of an IDE supplement
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 22 Jul 2020
Jazz Pharmaceuticals Announces U.S. FDA Approval of Xywav(TM) (calcium, magnesium, potassium, and sodium oxybates) Oral Solution for Cataplexy or Excessive Daytime Sleepiness Associated with Narcolepsy
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Jul 2020
BD receives FDA Approval for HPV Test with Extended Genotyping Capabilities
Diagnostics Oncology FDA
 HSMN NewsFeed - 22 Jul 2020
Luminex Files for Emergency Use Authorization for Expanded NxTAG Respiratory Panel Test Including SARS-CoV-2
Diagnostics FDA
 HSMN NewsFeed - 21 Jul 2020
LifeSignals Wireless Medical Biosensor LP1250 receives FDA clearance
Devices Monitoring FDA
 HSMN NewsFeed - 21 Jul 2020
Channel Medsystems(R) Receives FDA Approval of its Latest Cerene(R) Cryotherapy Device for the Treatment of Heavy Menstrual Bleeding in the Office Setting
Devices FDA
 HSMN NewsFeed - 20 Jul 2020
FDA Clears Abivertinib for Phase 2 Safety and Efficacy Study in Hospitalized Patients with Moderate To Severe Covid-19
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jul 2020
FX Solutions, SAS. [FX Shoulder, Inc.] Receives FDA 510k Clearances for TiN (Titanium Nitride) Coated Humeral Heads and Glenospheres
Devices Orthopaedic FDA
 HSMN NewsFeed - 20 Jul 2020
Luminex Receives FDA Emergency Use Authorization for COVID-19 Antibody Test
Diagnostics FDA
 HSMN NewsFeed - 15 Jul 2020
Edwards' KONECT RESILIA Aortic Valved Conduit Receives FDA Approval For Complex Aortic Valve Surgeries
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 15 Jul 2020
Paragon 28, Inc. is pleased to announce that the U.S. Food and Drug Administration has cleared the APEX 3D(TM) Total Ankle Replacement System
Devices Orthopaedic FDA
 HSMN NewsFeed - 14 Jul 2020
FDA Grants the Doraya AHF Catheter Breakthrough Designation
Devices Cardiology FDA
 HSMN NewsFeed - 14 Jul 2020
GI Supply Gets FDA Clearance of First Submucosal Lifting Agent in a Pre-filled 5mL Syringe
Devices Gastroenterology FDA
 HSMN NewsFeed - 14 Jul 2020
TREMFYA(R) (guselkumab) Approved by U.S. Food and Drug Administration as the First Selective Interleukin (IL)-23 Inhibitor for Active Psoriatic Arthritis
Biopharmaceuticals FDA
 HSMN NewsFeed - 10 Jul 2020
World's First FDA IDE Coronary Patient Treated With a DEB
Devices Interventional Cardiology
 HSMN NewsFeed - 6 Jul 2020
Cochlear obtains FDA approval of Kanso 2 Sound Processor, first off-the-ear cochlear implant sound processor with direct smartphone connectivity
Devices FDA
 HSMN NewsFeed - 6 Jul 2020
Abbott Receives FDA Approval for New Heart Rhythm Devices Featuring Bluetooth Connectivity and Continuous Remote Monitoring
Devices Cardiology FDA
 HSMN NewsFeed - 6 Jul 2020
BD Launches Portable, Rapid Point-of-Care Antigen Test to Detect SARS-CoV-2 in 15 minutes, Dramatically Expanding Access to COVID-19 Testing
Diagnostics FDA Product Launch
 HSMN NewsFeed - 1 Jul 2020
Engage Surgical Announces FDA 510(k) Clearance And Limited Market Release Of The Cementless Engage(TM) Partial Knee System
Devices Orthopaedic FDA
 HSMN NewsFeed - 1 Jul 2020
Carag Receives U.S. FDA IDE Approval to Conduct Clinical Study of First Transcatheter Septal Occluder With Bioresorbable, Metal-free Framework
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 29 Jun 2020
Boston Scientific Receives FDA 510(k) Clearance for the LUX-Dx(TM) Insertable Cardiac Monitor System
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 29 Jun 2020
SFA Therapeutics Announces FDA Approval To Begin IND Trial
Biopharmaceuticals Dermatology
 HSMN NewsFeed - 26 Jun 2020
Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Jun 2020
Polynoma Receives FDA Fast Track Designation for its Melanoma Cancer Vaccine Seviprotimut-L
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Jun 2020
Preceptis Medical announces the Hummingbird(R) device has received FDA 510(k) clearance for ear tube placement in young children in the ENT's office without general anesthesia
Devices FDA
 HSMN NewsFeed - 22 Jun 2020
FDA Accepts Supplemental Biologics License Application (sBLA) for BOTOX(R) (onabotulinumtoxinA) for the Treatment of Pediatric Patients with Neurogenic Detrusor Overactivity
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 22 Jun 2020
Cipla Launches CIPREMI (remdesivir Lyophilised Powder for Injection 100 mg), the Only U.S. FDA Approved Emergency Use Authorisation (EUA) Treatment for Patients With Severe COVID-19 Disease
Biopharmaceuticals Product Launch
 HSMN NewsFeed - 18 Jun 2020
Almirall Announces FDA Approval Of Updated Label For Seysara(R) (Sarecycline) Tablets
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 15 Jun 2020
Abbott's FreeStyle(R) Libre 2 iCGM Cleared in U.S. for Adults and Children with Diabetes, Achieving Highest Level of Accuracy and Performance Standards
Devices Monitoring Endocrinology FDA
 HSMN NewsFeed - 11 Jun 2020
CNS Announces the FDA has Granted Orphan Drug Designation for Brain Cancer Drug Berubicin
Biopharmaceuticals Oncology Neurology FDA
 HSMN NewsFeed - 11 Jun 2020
Lannett Provides Update On Clinical Advancement Of Biosimilar Insulin Glargine, Following FDA Meeting
Biopharmaceuticals Generics FDA
 HSMN NewsFeed - 10 Jun 2020
FDA Issues Emergency Use Authorization for ChromaCode's High-Throughput HDPCR(TM) SARS-CoV-2 Real-Time PCR Assay
Diagnostics FDA
 HSMN NewsFeed - 10 Jun 2020
F2G's Olorofim Receives Both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP Designation for Multiple Fungal Infections
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Jun 2020
FDA Grants EUA to Rapid COVID-19 Antibody Testing Product Distributed by Premier Biotech
Diagnostics FDA
 HSMN NewsFeed - 9 Jun 2020
BioMedInnovations LLC Announces U.S. Food and Drug Administration Has Granted Emergency Use Authorization to Manufacture and Distribute SuppleVent(TM), a Unique and Value-Added Ventilator Technology
Devices FDA
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