MedTech News
.................... by Andrew Celentano

Scientists develop mini human heart organoid that mimics atrial fibrillation
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.

Inside information: Bioretec has been granted FDA Breakthrough Device Designation status for its RemeOs™ DrillPin
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.

Peijia Medical Receives NMPA Approval for TaurusTrio Transcatheter Aortic Valve System, Pioneering Treatment for Aortic Regurgitation in China
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.

Bioluminescent tool captures neural activity without external lasers
A decade ago, a group of scientists had the literally brilliant idea to use bioluminescent light to visualize brain activity.

P&F secures FDA approval for TRICAV II pivotal clinical trial for severe tricuspid regurgitation
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.

Tanning beds triple melanoma risk, potentially causing broad DNA damage
Study is first to show how tanning beds mutate skin cells far beyond the reach of ordinary sunlight

FDA clears Bendit’s steerable vascular microcatheter
The Bendit17 steerable microcatheter aims to advance navigational control through complex anatomies in vascular procedures.

FDA Approves Zenflow Spring Implant and Delivery System for BPH
The Spring is the only FDA-approved FIT in a range of lengths and diameters, allowing for patient personalisation