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The Healthcare Sales & Marketing Network celebrates 28 years serving the medical sales & marketing community.Connecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product LinesConnecting Medical Sales Reps with MedTech/BioPharma Recruiters and Independent Reps with and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 13 Mar 2024
Ventris Medical Receives 510(k) Additional Clearance for Amplify(R) Standalone Bone Graft Putty
Devices FDA
 HSMN NewsFeed - 11 Mar 2024
FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA(R) (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children
Biopharmaceuticals FDA
 HSMN NewsFeed - 8 Mar 2024
U.S. Food and Drug Administration to Convene Advisory Committee Meeting to Discuss the TRAILBLAZER-ALZ 2 Study of Donanemab
Biopharmaceuticals Neurology FDA
 HSMN NewsFeed - 5 Mar 2024
ADI Announces U.S. FDA 510(k) Clearance and the Commercial Launch of Sensinel by Analog Devices(TM) Cardiopulmonary Management (CPM) System
Devices Cardiology Monitoring FDA
 HSMN NewsFeed - 1 Mar 2024
Mallinckrodt Announces U.S. FDA Approval of Supplemental New Drug Application for Acthar(R) Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect(TM) Injector
Devices Biopharmaceuticals Drug Delivery FDA
 HSMN NewsFeed - 1 Mar 2024
Boston Scientific Receives FDA Approval for the AGENT(TM) Drug-Coated Balloon
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 27 Feb 2024
Nuvalent Receives U.S. FDA Breakthrough Therapy Designation for NVL-520
Biopharmaceuticals Oncology FDA
 HSMN NewsFeed - 23 Feb 2024
BrainStorm Cell Therapeutics Submits Special Protocol Assessment (SPA) Request to FDA for Phase 3b Trial of NurOwn(R) in ALS
Regenerative Medicine Neurology FDA
 HSMN NewsFeed - 22 Feb 2024
Zimmer Biomet Receives FDA Clearance for ROSA(R) Shoulder System - the World's First Robotic Assistant for Shoulder Replacement Surgery
Devices Orthopaedic FDA
 HSMN NewsFeed - 21 Feb 2024
Sira Medical Wins FDA Clearance for Augmented Reality Preoperative Surgical Planning Software
Devices Surgery FDA
 HSMN NewsFeed - 20 Feb 2024
Avidity Biosciences Receives FDA Rare Pediatric Disease Designation for AOC 1044 for Treatment of Duchenne Muscular Dystrophy in People with Mutations Amenable to Exon 44 Skipping
Biopharmaceuticals FDA
 HSMN NewsFeed - 14 Feb 2024
Efemoral Medical Granted Breakthrough Device Designation
Devices Interventional FDA
 HSMN NewsFeed - 6 Feb 2024
Zynex Receives FDA Clearance for its Next Generation NMES Device
Devices FDA
 HSMN NewsFeed - 6 Feb 2024
FDA Clears Groundbreaking Corplex P(TM): The First Human Umbilical Cord-Derived Medical Device
Devices Wound Care FDA
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