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Healthcare News Roundup: FDA

 HSMN NewsFeed - 18 Sep 2019
OrthoSpin Receives FDA Regulatory Clearance
Devices Orthopaedic FDA
 HSMN NewsFeed - 16 Sep 2019
Seattle Genetics and Astellas Announce U.S. FDA Grants Priority Review for Enfortumab Vedotin Biologics License Application in Locally Advanced or Metastatic Urothelial Cancer
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 16 Sep 2019
Gala Therapeutics Receives FDA Breakthrough Device Designation for the Minimally Invasive RheOx(TM) System for Chronic Bronchitis
Devices FDA
 HSMN NewsFeed - 16 Sep 2019
Zimmer Biomet Receives FDA Clearance of JuggerStitch(TM) Meniscal Repair Device
Devices Orthopaedic FDA
 HSMN NewsFeed - 12 Sep 2019
Healthy.io Raises $60 Million in Series C Funding and Receives FDA Clearance for Smartphone-Based Test to Diagnose Chronic Kidney Disease
Diagnostics Venture Capital Personnel FDA
 HSMN NewsFeed - 11 Sep 2019
Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations
Biopharmaceuticals Oncology
 HSMN NewsFeed - 9 Sep 2019
Zimmer Biomet Commences Commercial Release of Persona(R) Revision Knee System
Devices Orthopaedic FDA Product Launch
 HSMN NewsFeed - 6 Sep 2019
Bardy Diagnostics(TM) Receives FDA 510(k) Clearance for 14-Day Carnation Ambulatory Monitor (CAM) Patch
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 5 Sep 2019
Arthrosurface Receives FDA Clearance for BOSS(TM) Toe Fixation System
Devices Orthopaedic FDA
 HSMN NewsFeed - 3 Sep 2019
Laboratory for Advanced Medicine Receives FDA Breakthrough Device Designation for Liquid Biopsy Liver Cancer Detection Test
Diagnostics Oncology FDA
 HSMN NewsFeed - 3 Sep 2019
Allergan Receives FDA Approval of Juvéderm VOLUMA(R) XC For Mid-Face Injection Via Cannula
Biopharmaceuticals Devices Dermatology FDA
 HSMN NewsFeed - 26 Aug 2019
FDA Clears Biobeat's Wearable Watch and Patch for Non-invasive Cuffless Monitoring of Blood Pressure
Devices Monitoring Cardiology FDA
 HSMN NewsFeed - 26 Aug 2019
Lilly Receives U.S. FDA Approval for Taltz(R) (ixekizumab) for the Treatment of Active Ankylosing Spondylitis (Radiographic Axial Spondyloarthritis)
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Aug 2019
Drawbridge Health Receives FDA 510(k) Clearance for OneDraw(TM) A1C Test System
Devices Diagnostics FDA
 HSMN NewsFeed - 20 Aug 2019
Eiger Announces FDA Breakthrough Therapy Designation for Peginterferon Lambda for Treatment of Hepatitis Delta Virus Infection
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Aug 2019
Vyaire Medical Receives FDA Clearance of New Pulmonary Function Testing Technology
Devices Diagnostics FDA
 HSMN NewsFeed - 19 Aug 2019
Vanda Pharmaceuticals FDA Update for HETLIOZ(R) in the Treatment of Jet Lag Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 16 Aug 2019
Zimmer Biomet's Innovative Treatment for Young Patients with Scoliosis Receives FDA Approval
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 15 Aug 2019
V-Wave's Interatrial Shunt Receives FDA Breakthrough Device Designation for Heart Failure
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 15 Aug 2019
Harmony Biosciences Announces FDA Approval of WAKIX(R) (Pitolisant), a First-in-Class Medication for the Treatment of Excessive Daytime Sleepiness in Adult Patients with Narcolepsy
Biopharmaceuticals FDA
 HSMN NewsFeed - 13 Aug 2019
FDA Approves EYLEA(R) (aflibercept) Injection Prefilled Syringe
Biopharmaceuticals Drug Delivery Ophthalmology FDA
 HSMN NewsFeed - 12 Aug 2019
binx health Receives FDA 510(k) Clearance For Rapid Point Of Care Platform For Women's Health
Diagnostics FDA
 HSMN NewsFeed - 12 Aug 2019
Shimadzu Medical Systems receives FDA 510(k) for the FLUOROspeed X1 RF system
Devices Radiology FDA
 HSMN NewsFeed - 5 Aug 2019
AbbVie Submits New Drug Application to US FDA for Investigational Elagolix for Management of Heavy Menstrual Bleeding Associated with Uterine Fibroids in Women
Biopharmaceuticals FDA
 HSMN NewsFeed - 5 Aug 2019
Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Biopharmaceuticals Dermatology FDA
 HSMN NewsFeed - 5 Aug 2019
Bracco Diagnostics Inc. Receives U.S. FDA Approval for VARIBAR(R) THIN LIQUID (barium sulfate) for oral suspension
Biopharmaceuticals Radiology Gastroenterology FDA
 HSMN NewsFeed - 2 Aug 2019
Endo Applauds U.S. District Court Decision that Vasopressin Cannot be Used for Compounding by Outsourcing Facilities
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 1 Aug 2019
Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo(R) (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma
Biopharmaceuticals Oncology
 HSMN NewsFeed - 30 Jul 2019
Alfa Plus by Solio Receives FDA Clearance: Unique Device Delivers Pain Relief Without Pharmaceuticals
Devices FDA Product Launch
 HSMN NewsFeed - 29 Jul 2019
Epygenix Therapeutics Receives IND Approval of EPX-100 for the Treatment of Dravet Syndrome
Biopharmaceuticals Neurology FDA
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