Zephyrus Innovations (Zephyrus), a privately-owned medical device company designing and manufacturing safety syringes and Closed System Transfer Devices (CSTDs), today announces that it has received product 510(k) Marketing Clearance from the US Food and Drug Administration (“FDA”) for its VaporShield ™ CSTD.
New production capacity strengthens MPM Medical’s position as a leading U.S. manufacturer and follows the company’s recent launch of collagen at-home wound care kits
According to a US pivotal study, the device’s sensitivity has been reported at more than 76% on all specimens.
BlueWind Medical announced today that the FDA granted 510(k) clearance for its enhanced Revi implantable tibial neuromodulation (iTNM) system.
Medivis announced today that it received FDA 510(k) clearance for its augmented reality (AR)-powered Cranial Navigation platform.
The Anavi system treats polycystic ovary syndrome by delivering targeted radiofrequency energy to ablate ovarian tissue to re-initiate ovulatory cycles.
The patch is tailored to deliver all types of vaccines to the skin using a simple applicator.
The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system.
TAMPERE, Finland, Dec. 14, 2025 /PRNewswire/ — Bioretec Oy (“Bioretec” or the “Company”), a pioneer in biodegradable orthopedic implants, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its magnesium alloy technology-based, biodegradable RemeOs™ DrillPin.
HONG KONG, Dec. 12, 2025 /PRNewswire/ — Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its TaurusTrio Transcatheter Aortic Valve (TAV) system received approval from the National Medical Products Administration (NMPA) of China on December 11, 2025.