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.
Vara has announced that it has received a new CE certificate for its new breast-imaging AI.
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.
BVI announced today that the FDA approved its FineVision HP trifocal intraocular lens (IOL) for cataract surgery.
Zeta Surgical this week announced it received FDA 510(k) clearance for its Zeta TMS Navigation System
Pleural Dynamics announced today that it received a new CMS code for its ACES (automatic continuous effusion shunt) device.
Medtronic (NYSE: MDT)+
announced today that it received new labeling approval from the FDA for its Endurant stent graft system.
OrthoIndy spine surgeon Dr Greg Poulter performed the inaugural SyncAR Spine case.
The xStep device offers painless, non-invasive electrical stimulation to the spinal cord to treat paralysis.