Category: Uncategorized - Page 55 - Start Medical Product Development

Scientists develop mini human heart organoid that mimics atrial fibrillation

December 14, 2025

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

December 14, 2025

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

December 12, 2025

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

December 12, 2025

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

December 12, 2025

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

December 12, 2025

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

December 12, 2025

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

December 12, 2025

The Spring is the only FDA-approved FIT in a range of lengths and diameters, allowing for patient personalisation

European researchers developed energy-efficient machine vision inspired by human eyesight and the brain

December 11, 2025

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.

Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology

December 11, 2025

PLANO, Texas, Dec. 11, 2025 /PRNewswire/ — Vesalio, a leader in thrombectomy solutions, today announced FDA 510(k) clearance and the upcoming U.S. commercial launch of enVast™, the first and only clot retriever specifically cleared for mechanical thrombectomy in the cardiac circulation. enVast introduces a proven, innovative approach to clot capture and removal, redefining coronary thrombectomy for patients with large thrombus burden (LTB).

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- Uncategorized

Scientists develop mini human heart organoid that mimics atrial fibrillation

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

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

Bioluminescent tool captures neural activity without external lasers

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

Tanning beds triple melanoma risk, potentially causing broad DNA damage

FDA clears Bendit’s steerable vascular microcatheter

FDA Approves Zenflow Spring Implant and Delivery System for BPH

European researchers developed energy-efficient machine vision inspired by human eyesight and the brain

Vesalio Receives FDA 510(k) Clearance of enVast, the First Stent-Based Coronary Thrombectomy Technology