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Healthcare News Roundup: FDA

 HSMN NewsFeed - 24 Jan 2023
FDA Agrees to Expanded Access Program for the BioVentrix(R) Revivent TC(R) System for the Treatment of Ischemic Heart Failure
Devices Cardiology FDA
 HSMN NewsFeed - 23 Jan 2023
Cadrenal Therapeutics (Nasdaq: CVKD) Granted FDA Fast Track Designation for Tecarfarin for Prevention of Systemic Thromboembolism of Cardiac Origin in Patients with End-Stage Renal Disease and Atrial Fibrillation
Biopharmaceuticals FDA
 HSMN NewsFeed - 20 Jan 2023
RenalGuard Therapy(R) Receives FDA Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI
Devices Cardiology Surgery FDA
 HSMN NewsFeed - 20 Jan 2023
Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Biopharmaceuticals FDA
 HSMN NewsFeed - 19 Jan 2023
Conventus Flower Orthopedics Announces Expansion of its Flex-Thread(TM) Technology Platform with FDA Clearance of the Ulna Intramedullary Nail System
Devices Orthopaedic FDA
 HSMN NewsFeed - 11 Jan 2023
MedAlliance SELUTION SLR is the first DEB to receive coronary de novo IDE approval, its fourth FDA IDE DEB Approval
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 10 Jan 2023
Arthrex Receives FDA Clearance for TightRope(R) Implant as First, Only Device Cleared for Pediatric ACL Surgery
Devices Orthopaedic FDA
 HSMN NewsFeed - 29 Dec 2022
FDA Grants Appeal for Ardelyx's XPHOZAH(R) (tenapanor)
Biopharmaceuticals Cardiology FDA
 HSMN NewsFeed - 27 Dec 2022
BrainStorm Cell Therapeutics Announces Type A Meeting with FDA Granted for NurOwn(R)
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 26 Dec 2022
Harm Reduction Therapeutics' New Drug Application for RiVive(TM) Over-the-Counter Naloxone Nasal Spray Accepted and Granted Priority Review by FDA
Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 20 Dec 2022
Insightec Receives FDA Approval to Treat Essential Tremor Patients' Second Side, Expanding Total Available Market in United States
Devices Neurology FDA
 HSMN NewsFeed - 20 Dec 2022
SURGLASSES received FDA 510(k) Clearance for Caduceus S
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 19 Dec 2022
Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Cord Stimulation System for Chronic Pain
Devices FDA Product Launch
 HSMN NewsFeed - 15 Dec 2022
Providence Medical Technology announces FDA Clearance of the CAVUX(R) Facet Fixation System for the treatment of Cervical Pseudarthrosis
Devices Neurosurgery Orthopaedic FDA
 HSMN NewsFeed - 12 Dec 2022
IRRAS Receives US FDA 510(k) Clearance for its Next Generation IRRAflow Control Unit
Devices Neurosurgery FDA
 HSMN NewsFeed - 9 Dec 2022
Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 5 Dec 2022
Deep Blue Medical Advances Announces FDA Clearance for Sublay Application in Hernia Surgery, Enabling Broader Use of T-Line Hernia Mesh
Devices Surgery FDA
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