Continuous dialysis implant wins FDA Breakthrough Device Designation
December 15, 2025
The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system.
The FDA has granted Breakthrough Device Designation to Nephrodite’s Holly implantable continuous dialysis system.
Though an estimated 60 million people around the world have atrial fibrillation, or A-fib, a type of irregular and often fast heartbeat, it’s been at least 30 years since any new treatments have been developed. This is because researchers haven’t had accurate models of the human heart to study. Thanks to new developments from Michigan State University scientists, that is no longer the case.
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.
A decade ago, a group of scientists had the literally brilliant idea to use bioluminescent light to visualize brain activity.
P&F USA, Inc., the U.S. subsidiary of heart valve manufacturer P&F Products and Features GmbH, today announced that the U.S. Food and Drug Administration (FDA) has approved initiation of the TRICAV II Pivotal Trial.
Study is first to show how tanning beds mutate skin cells far beyond the reach of ordinary sunlight
The Bendit17 steerable microcatheter aims to advance navigational control through complex anatomies in vascular procedures.
The Spring is the only FDA-approved FIT in a range of lengths and diameters, allowing for patient personalisation
A European research project led by VTT has developed machine vision mimicking the cooperation of the eye and nervous system, implemented as edge-computing circuits.