MedTech News
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.
New brain implant delivers drugs to multiple regions with high precision
Researchers at NYU Abu Dhabi (NYUAD) have developed a new type of brain implant that can deliver drugs to multiple regions of the brain with high precision, offering fresh possibilities for the treatment of neurological disorders.
Eco-friendly silicon patch delivers clearer ultrasound images without harmful lead components
Wearable ultrasound devices are actively used in various medical settings, including hospital diagnostics, rehabilitation monitoring, and telemedicine. However, most commercial devices currently rely on lead (Pb)-based piezoelectric ceramics, which are harmful to the human body and the environment, making it difficult to ensure both performance and safety.
BVI wins FDA nod for trifocal intraocular lens
BVI announced today that the FDA approved its FineVision HP trifocal intraocular lens (IOL) for cataract surgery.
Zeta Surgical wins FDA clearance for TMS navigation system
Zeta Surgical this week announced it received FDA 510(k) clearance for its Zeta TMS Navigation System