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Healthcare News Roundup: FDA

 HSMN NewsFeed - 18 Oct 2019
Nplate(R) (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia
Biopharmaceuticals FDA
 HSMN NewsFeed - 18 Oct 2019
FDA Clears ORTHO(TM) Sera ID-MTS for Use on the ORTHO VISION(R) Analyzer
Diagnostics FDA
 HSMN NewsFeed - 17 Oct 2019
CarboFix Extends Its CarboClear(R) Carbon Fiber Spinal Product Line With Its FDA Cleared Vertebral Body Replacement (VBR) System
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 16 Oct 2019
Fidmi Medical Receives FDA Regulatory Clearance for Low-profile Enteral Feeding Device
Devices FDA
 HSMN NewsFeed - 15 Oct 2019
BIOLASE Announces First-Ever U.S. & Canada Regulatory Clearance of Laser Crown and Veneer Removal
Devices Dental FDA Regulatory
 HSMN NewsFeed - 14 Oct 2019
OssDsign Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US
Devices Neurosurgery FDA
 HSMN NewsFeed - 10 Oct 2019
FDA Clears GEKO DEVICE for Use in Non-surgical Patients at Risk for Deep Vein Thrombosis Based on Study Demonstrating a Zero Percent DVT Rate in Patients After a Stroke
Devices FDA
 HSMN NewsFeed - 10 Oct 2019
FDA Grants Ofev(R) Breakthrough Therapy Designation for Chronic Fibrosing ILDs with a Progressive Phenotype
Biopharmaceuticals FDA
 HSMN NewsFeed - 9 Oct 2019
Corvia Medical's Interatrial Shunt Device (IASD(R)) Receives Breakthrough Device Designation For Heart Failure
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 8 Oct 2019
Sekisui Diagnostics Announces FDA Clearance and CLIA Waiver of the Acucy(TM) Influenza A&B Test
Diagnostics FDA
 HSMN NewsFeed - 7 Oct 2019
ProTom Receives U.S. FDA 510(k) Clearance for Its Radiance 330(R) Single Room Proton Therapy System
Devices Oncology FDA
 HSMN NewsFeed - 2 Oct 2019
Blood Flow Monitoring Device - FlowMet-R Gets FDA 510K Clearance
Devices Monitoring FDA
 HSMN NewsFeed - 2 Oct 2019
DURECT Announces FDA Advisory Committee Meeting to Review POSIMIR(R) for the Treatment of Post-Surgical Pain
Biopharmaceuticals Drug Delivery Surgery FDA
 HSMN NewsFeed - 30 Sep 2019
Endo Announces Successful Culmination of Litigation Regarding FDA Compounding Policy
Biopharmaceuticals Generics FDA Litigation
 HSMN NewsFeed - 26 Sep 2019
FDA Approves Abbott's "Low Dose," Recharge-Free Spinal Cord Stimulation System with up to Ten Year Battery Life* for People Living with Chronic Pain
Devices Neurology FDA
 HSMN NewsFeed - 24 Sep 2019
Emmaus Life Sciences Reinforces Positive Outcomes of Endari(R) Clinical Trials, Including Efficacy Findings That Led to FDA Approval
Biopharmaceuticals
 HSMN NewsFeed - 23 Sep 2019
Cologuard(R) Gains FDA Approval For Use In Younger Americans, Ages 45 To 49
Diagnostics Oncology 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
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