MedTech News
Stereotaxis wins CE mark for Synchrony system, submits to FDA
Stereotaxis (NYSE:STXS) announced today that it received CE mark for its Synchrony system while also submitting it to the FDA for 510(k) clearance.
NextBiomedical begins US pivotal trial for Nexsphere-F knee pain device
NextBiomedical this week announced it enrolled the first patient in its U.S. pivotal clinical trial evaluating its Nexsphere-F, a fast-resorbable microsphere for embolization treatment of musculoskeletal pain.
Globus Medical launches Anthem Elbow Fracture System
Globus Medical has launched the Anthem Elbow Fracture System, a plating system designed to help surgeons manage a wide range of elbow fractures with simplified workflow and flexible fixation options.
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.