MedTech News
.................... by Andrew Celentano
Vara earns CE mark for AI breast imaging
Vara has announced that it has received a new CE certificate for its new breast-imaging AI.
Stereotaxis teams with CardioFocus to develop robotic PFA system
https://www.medtechdive.com/news/stereotaxis-teams-with-cardiofocus-to-develop-robotic-pfa-system/802799/
GE HealthCare launches perinatal care platform
Designed alongside HCA Healthcare, CareIntellect aims to simplify patient monitoring in perinatal care.
Precise gene editing technique changes one DNA base to correct heart disease
Faulty versions of the LMNA gene can cause a wide range of health problems, including heart muscle disease (dilated cardiomyopathy) and muscle weakness (muscular dystrophies). Many of these diseases are caused by single-point mutations, which are changes to one DNA “letter” (base).
Simergent Announces FDA Clearance of the Archimedes™ Home Dialysis System
OKLAHOMA CITY and CHICAGO, Oct. 14, 2025 /PRNewswire/ — Simergent, a privately held company dedicated to advancing treatment for patients with kidney failure, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the company’s Archimedes™ automated peritoneal dialysis (APD) system for the treatment of patients with End Stage Kidney Disease (ESKD) in clinical and home settings.
Centinel Spine® Receives Two-Level FDA Approval for prodisc® C Vivo and prodisc® C SK Match-the-Disc™ Cervical Total Disc Replacement Devices
WEST CHESTER, Pa., Oct. 14, 2025 /PRNewswire/ — Centinel Spine®, LLC (“the Company”), the leading global medical device company focused exclusively on treating cervical and lumbar spinal disease with the most complete and clinically-proven total disc replacement (TDR) technology platform in the world (prodisc®), today announced U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) for 2-level indications for the prodiscC Vivo and prodisc C SK Cervical TDR devices. Since receiving FDA approval for 1-level indications in July 2022, nearly 20,000 prodiscC Vivo and prodisc C SK spinal levels have been implanted in the U.S. by over 1,100 surgeons.
New brain-scanning method could help improve how anxiety is understood and diagnosed
A study by the University of Portsmouth in England has mapped the biological journey of anxiety in the brain when people are faced with a no-win situation.
Human liver organoid platform can predict immune-mediated drug toxicity
Researchers at Cincinnati Children’s Hospital Medical Center in collaboration with Roche, have developed a next-generation human liver organoid microarray platform that could help predict which drugs may cause harmful immune reactions in some people.