MedTech News
icotec Receives FDA Clearance for the CMORE® CT System, Expanding its BlackArmor® Engineered Carbon/PEEK Technology to the Posterior Cervicothoracic Spine
ALTSTÄTTEN, Switzerland and BOSTON, Nov. 13, 2025 /PRNewswire/ — icotec, the pioneer of implantable devices made from BlackArmor® Engineered Carbon/PEEK, today announced that the U.S. Food and Drug Administration (FDA) has cleared the CMORE® CT System for use in the cervicothoracic spine.
Smart Sound Ltd. Announces Patent Publication for Groundbreaking Hidden Cochlear Implant System
NIRIT, Israel, Nov. 13, 2025 /PRNewswire/ — Smart Sound Ltd., a cochlear implant innovator, announces publication of a U.S. Patent for a “Hidden Cochlear Implant System with an In-Canal Wireless Transmission,” a novel cochlear implant design fundamentally change the industry by providing a fully discreet, magnet-free and improving users quality of life.
Rapid Nexus Becomes the First Company to Receive FDA Clearance for its Advanced Wound-Healing Device Hemastyl
BREA, Calif., Nov. 13, 2025 /PRNewswire/ — Rapid Nexus Nanotech Wound Solutions, Inc., a California-based med-tech company focused on advanced wound care, today announced it has received FDA 510(k) clearance for its Hemastyl gel device—marking a historic milestone as the first company to directly target the underlying reason chronic wounds fail to heal.
Integra wins FDA nod for ultrasonic surgical aspiratory system for cardiac surgeries
Integra LifeSciences (Nasdaq: IART)+
announced that it received FDA 510(k) clearance for its CUSA aspirator system for cardiac surgeries.
AI-powered app measuring menstrual volume launches in UK
In a move for women’s health, menstrual health startup Joii is launching the world’s first AI-powered app that accurately measures period blood volume in the UK, transforming a guessing game into hard data that benefits patients and clinicians alike.
BD Expands PureWick™ Portfolio with First-of-its-Kind Portable Solution to Confidently Manage Urinary Incontinence On the Go
FRANKLIN LAKES, N.J., Nov. 12, 2025 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, introduces the PureWick™ Portable Collection System, a discreet, first-of-its-kind, battery-powered personal urine management device designed for wheelchair users to help improve mobility around and outside the home.
Hubly Surgical Auto-Stop Drill Receives FDA 510(k) Clearance for Spinal Decompression Surgery: Laminectomy and Laminotomy
LISLE, Ill., Nov. 12, 2025 /PRNewswire/ — Hubly Surgical today announced FDA 510(k) clearance expanding Hubly Auto-Stop Drill indications to include spinal decompression procedures. To date, many thousands of neurosurgical patient lives have been saved using Hubly Auto-Stop Drills; the device’s SMART auto-stop halts rotation and prevents forward plunge at the instant of skull penetration, preventing over-drilling into patients’ brains. The new clearance expands use to laminectomy and laminotomy for spinal decompression to drill through the vertebral lamina and protect patients from damage to the spinal cord.
Genetic testing trifecta predicts risk of sudden cardiac death and arrhythmia
New approach could be applied to other complex, genetically influenced diseases like cancer, Parkinson’s