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Healthcare News Roundup: FDA

 HSMN NewsFeed - 23 Jul 2018
MEDICALgorithmics, Medi-Lynx Receive FDA 510(K) Clearance for PocketECG CRS Mobile Cardiac Rehabilitation System
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 23 Jul 2018
Allergan Receives FDA Fast Track Designation for AGN-241751 for the Treatment of Major Depressive Disorder (MDD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 23 Jul 2018
Amneal Announces FDA Approval and Launch of Generic Potassium Chloride Oral Solution
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 20 Jul 2018
FDA Grants Approval of TIBSOVO(R), the First Oral, Targeted Therapy for Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia and an IDH1 Mutation
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 19 Jul 2018
BioPharmX Announces FDA Grant of CARC Waiver and Post-Hoc Analysis for BPX-01
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 18 Jul 2018
PainReform Gets FDA Approval for Phase III Post-Operative Pain Relief Study
Biopharmaceuticals Surgery FDA
 HSMN NewsFeed - 17 Jul 2018
Candela Announces FDA Clearance Of Vbeam(R) Prima
Devices Dermatology FDA
 HSMN NewsFeed - 17 Jul 2018
BAROnova Announces Submission of Premarket Approval (PMA) Application to the U.S. FDA for the TransPyloric Shuttle(R) (TPS(R)) Device Intended for the Treatment of Obesity
Devices FDA
 HSMN NewsFeed - 16 Jul 2018
Stryker receives US FDA Pre-market approval for the Surpass Streamline(TM) Flow Diverter to treat large and giant unruptured aneurysms
Devices Interventional Neurology Radiology FDA
 HSMN NewsFeed - 13 Jul 2018
Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY(TM) (romosozumab) To The US FDA
Biopharmaceuticals FDA
 HSMN NewsFeed - 12 Jul 2018
Gala Therapeutics Receives FDA IDE Approval for a US Early Feasibility Study of Its RheOx(TM) System to Treat Chronic Bronchitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 11 Jul 2018
FDA Accepts Biologics License Application For Subcutaneous Formulation Of Herceptin
Biopharmaceuticals Drug Delivery Oncology FDA
 HSMN NewsFeed - 9 Jul 2018
Oculocare's Alleye(R) Receives FDA 510(k) Clearance for Monitoring Eyesight in AMD
Devices Diagnostics Ophthalmology FDA
 HSMN NewsFeed - 9 Jul 2018
Companion Medical Announces FDA Clearance for the InPen System for Android
Devices Endocrinology FDA
 HSMN NewsFeed - 9 Jul 2018
OBI Pharma Granted FDA Orphan Drug Designation for OBI-3424 for the Treatment of Hepatocellular Carcinoma (HCC)
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 6 Jul 2018
FDA Clears The Way: Lipogems' Receives FDA Clearance For Microfragmented Adipose Tissue System Utilizing Body's Own Fat To Support Tissue Repair In Orthopaedic And Arthroscopic Surgeries
Regenerative Medicine Orthopaedic FDA
 HSMN NewsFeed - 4 Jul 2018
Theratechnologies Submits Novel Single-Vial Formulation of EGRIFTA(R) (Tesamorelin for Injection) for FDA Approval
Biopharmaceuticals HIV/AIDS FDA
 HSMN NewsFeed - 28 Jun 2018
Renovis Surgical Receives FDA Clearance for Tesera Trabecular Technology(TM) Hyperlordotic ALIF Interbody Spinal Fusion System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 27 Jun 2018
Revive Therapeutics Announces FDA Grants Orphan Drug Designation for Cannabidiol in the Treatment of Autoimmune Hepatitis
Biopharmaceuticals FDA
 HSMN NewsFeed - 27 Jun 2018
Beckman Coulter Diagnostics Receives U.S. FDA 510(k) Clearance for High- sensitivity Access hsTnI Assay
Diagnostics Cardiology FDA
 HSMN NewsFeed - 25 Jun 2018
IMBRUVICA(R) (ibrutinib) Supplemental New Drug Application Accepted for Review by U.S. FDA with Potential to Broaden Treatment Use as a Combination Treatment Option with Rituximab in Waldenström's Macroglobulinemia (WM), A Rare Form of Blood Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 25 Jun 2018
Beckman Coulter Files a 510(k) Submission with the FDA for Its Early Sepsis Indicator*
Diagnostics FDA
 HSMN NewsFeed - 25 Jun 2018
FDA Authorizes FRESCA Medical To Market New Positive Airway Pressure Delivery System To Treat Sleep Apnea
Devices FDA
 HSMN NewsFeed - 22 Jun 2018
Impel NeuroPharma Announces FDA Clearance of IND for Pivotal Phase 3 Study of INP104 for Acute Treatment of Migraine
Biopharmaceuticals Drug Delivery Neurology FDA
 HSMN NewsFeed - 20 Jun 2018
Medtronic Announces Second Bone Cement Solution Indicated for Treating Sacral Fractures
Devices Interventional Radiology Orthopaedic FDA
 HSMN NewsFeed - 20 Jun 2018
AIVITA Biomedical Announces U.S. Food and Drug Administration Clearance of IND for Phase II Glioblastoma Multiforme Trial
Regenerative Medicine Oncology FDA
 HSMN NewsFeed - 19 Jun 2018
Grifols Expands its NAT Solutions Portfolio with New FDA Approvals for Two Assays
Diagnostics FDA
 HSMN NewsFeed - 18 Jun 2018
Arcuro Medical Receives FDA Regulatory Clearance
Devices Orthopaedic FDA
 HSMN NewsFeed - 15 Jun 2018
Medtronic Receives FDA Approval for 200mm & 250mm IN.PACT(TM) Admiral(TM) Drug Coated Balloons
Devices Interventional FDA
 HSMN NewsFeed - 14 Jun 2018
BlueWind Medical Receives FDA Approval for Pivotal Trial Design of RENOVA iStim(TM) Implantable Tibial Nerve Neuromodulator for Overactive Bladder
Devices Urology Neurology FDA
 HSMN NewsFeed - 12 Jun 2018
MicroVention Announces FDA Clearance For Thrombectomy Device
Devices Interventional Neurology FDA
 HSMN NewsFeed - 11 Jun 2018
OrthoSensor, Inc. Secures Additional 510(K) Clearance
Devices Orthopaedic FDA
 HSMN NewsFeed - 7 Jun 2018
Centinel Spine Announces 510(k) Clearance of FLX(TM) Platform of 3D Printed All-Titanium Interbodies
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 6 Jun 2018
Partner Therapeutics (PTx) Announces US FDA Approval of Leukine(R) (sargramostim) for the Treatment of Acute Radiation Syndrome
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Jun 2018
Philips receives U.S. FDA 510(k) clearance for its Ingenia Elition MR solution
Devices Radiology FDA
 HSMN NewsFeed - 5 Jun 2018
FDA Expands Lilly's ALIMTA(R) (pemetrexed) Label to Include Combination with KEYTRUDA(R) (pembrolizumab) and Carboplatin as First-Line Treatment for Metastatic Nonsquamous Non-Small Cell Lung Cancer, Irrespective of PD-L1 Expression
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 4 Jun 2018
Camber Spine Announces 510(k) Approval Of ENZA(TM)-A Titanium ALIF
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 1 Jun 2018
Lannett Receives FDA Approval For Levofloxacin Oral Solution; Imminent Launch Anticipated
Biopharmaceuticals Generics FDA Product Launch
 HSMN NewsFeed - 31 May 2018
Curis Announces FDA Fast Track Designation for Fimepinostat Development in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 31 May 2018
Encision Inc. Applauds the FDA's Safety Communication On The Dangers Of Monopolar Electrosurgery
Devices Surgery FDA
 HSMN NewsFeed - 30 May 2018
Legend Announces FDA Clearance of IND Application on CAR-T Immuno-cell Therapy for the Treatment of Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 30 May 2018
FDA expedites review of Novartis drug Promacta(R) for first-line severe aplastic anemia (SAA)
Biopharmaceuticals FDA
 HSMN NewsFeed - 30 May 2018
FDA Broadens ClearGuard(R) HD Antimicrobial Barrier Cap Indications
Devices FDA
 HSMN NewsFeed - 29 May 2018
TrioxBio Announces Fast Track Designation Granted by U.S. FDA to Raviten(R) for the Treatment of Intradialytic Hypotension
Biopharmaceuticals FDA
 HSMN NewsFeed - 29 May 2018
Zeto Announces First Dry Electrode, Wireless EEG Headset Approved by FDA for Clinical Use
Devices Monitoring Neurology FDA
 HSMN NewsFeed - 29 May 2018
UCB Announces the Approval of CIMZIA(R) (certolizumab pegol) for Moderate-to-Severe Plaque Psoriasis, Representing an Important New Option for Patients in the U.S.
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 29 May 2018
U.S. FDA Grants Priority Review to Astellas' New Drug Application for Gilteritinib for the Treatment of Adult Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML)
Biopharmaceuticals Oncology FDA
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