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Healthcare News Roundup: 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
 HSMN NewsFeed - 26 Jul 2019
MiRus Receives FDA Clearance for Lowest Profile Anterior Cervical Plate System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 25 Jul 2019
U.S. FDA Accepts Correvio's Resubmitted New Drug Application For Brinavess (vernakalant)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 24 Jul 2019
FDA Takes Action to Protect Patients from Risk of Certain Textured Breast Implants; Requests Allergan Voluntarily Recall Certain Breast Implants and Tissue Expanders from Market
Devices FDA Product Recall
 HSMN NewsFeed - 24 Jul 2019
Exogenesis Corporation Announces the Filing of a 510(k) Pre-Marketing Notification Application with the US Food and Drug Administration for Exogenesis Hernia Mesh
Devices Surgery FDA
 HSMN NewsFeed - 23 Jul 2019
Lipocine Receives FDA Clearance for Clinical Testing its NASH Candidate, LPCN 1144, in Expanded Target Population
Biopharmaceuticals FDA
 HSMN NewsFeed - 22 Jul 2019
Vanda Pharmaceuticals FDA Update for HETLIOZ(R) in the Treatment of Jet Lag Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Jul 2019
FDA Clears Erchonia's FX 635 for Relief of Chronic Musculoskeletal Pain
Devices FDA
 HSMN NewsFeed - 17 Jul 2019
U.S. FDA Accepts Allergan's New Drug Application for Bimatoprost Sustained-Release in Patients with Open-Angle Glaucoma or Ocular Hypertension
Biopharmaceuticals Ophthalmology FDA
 HSMN NewsFeed - 17 Jul 2019
Q'Apel Medical Announces FDA Clearance for Walrus Balloon Guide Catheter
Devices Interventional FDA
 HSMN NewsFeed - 15 Jul 2019
Alkermes Expands Planned New Drug Application for ALKS 3831 to Include Treatment of Bipolar I Disorder
Biopharmaceuticals FDA
 HSMN NewsFeed - 15 Jul 2019
AirXpanders(R) Receives FDA 510(k) Clearance for a Smooth Shell Version of the AeroForm(R) Tissue Expander System
Devices Oncology Surgery FDA
 HSMN NewsFeed - 12 Jul 2019
Neovasc to Explore HDE Approval Pathway and Alternate Trial Designs for the Reducer Following Guidance from the FDA
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 11 Jul 2019
Abbott Announces FDA Approval of the Alinity(TM) s System, the Latest Technology for Screening and Protecting the U.S. Blood and Plasma Supply
Diagnostics FDA
 HSMN NewsFeed - 11 Jul 2019
RaySearch Receives FDA Clearance for RayStation 8B Including Machine Learning Functionalities
Devices Radiology Oncology FDA
 HSMN NewsFeed - 8 Jul 2019
BIOTRONIK Receives FDA Clearance on Next-Gen Injectable Cardiac Monitor: BIOMONITOR III
Devices Cardiology Monitoring FDA
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