Stereotaxis wins CE mark for Synchrony system, submits to FDA
October 15, 2025
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.
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 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 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 has announced that it has received a new CE certificate for its new breast-imaging AI.
https://www.medtechdive.com/news/stereotaxis-teams-with-cardiofocus-to-develop-robotic-pfa-system/802799/
Designed alongside HCA Healthcare, CareIntellect aims to simplify patient monitoring in perinatal care.
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).
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.
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.
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.