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The Healthcare Sales & Marketing Network celebrates 27 years serving the medical sales & marketing community.Connecting Medical Independent Sales Reps and Distributors with Manufacturers and New Product LinesConnecting Medical Independent Sales Reps and Distributors with Manufacturers and New Product Lines

Healthcare News Roundup: FDA

 HSMN NewsFeed - 3 Nov 2025
Alcresta Therapeutics Announces FDA Clearance for Expanded Use of RELiZORB(R) (iMMOBILIZED LIPASE) Cartridge for Neonates and Infants
Biopharmaceuticals FDA
 HSMN NewsFeed - 28 Oct 2025
Zimmer Biomet Announces FDA Breakthrough Designation for World's First Iodine-Treated Total Hip Replacement System
Devices Orthopaedic FDA
 HSMN NewsFeed - 24 Oct 2025
Terumo Interventional Systems Announces Its New OPUSWAVE(R) Dual Sensor Imaging System and DualView(R) Imaging Catheter Receive FDA 510(k) Clearance
Devices Interventional Cardiology FDA
 HSMN NewsFeed - 23 Oct 2025
Labcorp to Offer First FDA-Cleared Blood Test to Rule out Alzheimer's-Related Amyloid Pathology in Primary Care Settings
Diagnostics Neurology
 HSMN NewsFeed - 21 Oct 2025
Onkos Surgical(R) Receives FDA 510(k) Clearance for ELEOS(TM) Proximal Tibia with NanoCept(R) Antibacterial Technology
Devices Orthopaedic FDA
 HSMN NewsFeed - 15 Oct 2025
CAPS Medical's PlasmaSure(TM) Receives FDA Breakthrough Device Designation
Devices Oncology FDA
 HSMN NewsFeed - 13 Oct 2025
Zeta Surgical(R) AI-powered TMS Navigation System Receives FDA 510(k) Clearance
Devices Neurology FDA
 HSMN NewsFeed - 10 Oct 2025
Next-Generation AI-Driven SyncAR(R) Spine Receives FDA Clearance for Spine Surgery
Devices Orthopaedic Neurosurgery FDA
 HSMN NewsFeed - 29 Sep 2025
Novo Nordisk Resubmits Awiqli(R) to the FDA With Potential to be the First Once-Weekly Basal Insulin Treatment for Adults with Type 2 Diabetes
Biopharmaceuticals Endocrinology FDA
 HSMN NewsFeed - 24 Sep 2025
TSC Life Receives FDA 510(K) Clearance for Fluido(R) AirGuard System, a Moderate to High Flow Blood and IV Fluid Warming Solution for the Prevention of Hypothermia
Devices FDA
 HSMN NewsFeed - 19 Sep 2025
Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion(TM) BCP-PEEK Implant
Devices Neurosurgery FDA
 HSMN NewsFeed - 18 Sep 2025
J & D Pharmaceuticals LLC Receives Orphan Drug Designation for Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Biopharmaceuticals FDA
 HSMN NewsFeed - 17 Sep 2025
Amber Implants Secures FDA 510(k) Clearance for VCFix(R) Spinal System: A Next-Generation Solution for Vertebral Compression Fractures
Devices Orthopaedic Neurosurgery FDA
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