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Healthcare News Roundup: FDA

 HSMN NewsFeed - 14 Nov 2025
Zimmer Biomet Receives U.S. FDA Clearance for Enhanced Version of ROSA(R) Knee Robotic Technology
Devices Orthopaedic FDA
 HSMN NewsFeed - 13 Nov 2025
icotec Receives FDA Clearance for the CMORE(R) CT System, Expanding its BlackArmor(R) Engineered Carbon/PEEK Technology to the Posterior Cervicothoracic Spine
Devices Orthopaedic Neurosurgery 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 - 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
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