Author: Andrew Celentano - Page 96 - Start Medical Product Development

EYE PCR Receives CE Mark for fixOflex Endocapsular Device, Enabling European Market Introduction

February 13, 2026

HERAKLION, Greece, Feb. 13, 2026 /PRNewswire/ — EYE PCR announces that its fixOflex endocapsular device has received CE Mark certification under the European Union Medical Device Regulation (EU MDR 2017/745), enabling commercialization in Europe and other markets that recognize the CE Mark. This regulatory milestone validates the device’s safety and efficacy, positioning EYE PCR for controlled market introduction.

InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device

February 13, 2026

GALWAY, Ireland, Feb. 13, 2026 /PRNewswire/ — InVera Medical, an Irish medical technology company, has received European regulatory approval for a new minimally invasive device designed to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins.

World-First EXO 001 Exosome Platform Enables In Vivo Multi-Target CAR-T for Solid Tumors

February 13, 2026

TAICHUNG, Feb. 13, 2026 /PRNewswire/ — Cancer has long ranked among the leading causes of death in Taiwan, and solid tumors account for more than 90% of cancer cases worldwide—making them the most challenging frontier for CAR-T cell therapy. China Medical University Hospital (CMUH) announced today that, in collaboration with Ever Supreme Bio Technology, it has successfully developed the world’s first EXO 001 targeted exosome platform, a breakthrough technology that enables direct in vivo programming of T cells to generate multi-target nanobody-based CAR-T cells.

Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

February 13, 2026

GALWAY, Ireland, Feb. 13, 2026 /PRNewswire/ — Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced U.S. Food and Drug Administration (FDA) clearance of the Stealth AXiS™ surgical system, a next-generation platform that brings planning, navigation, and robotics together into a single, intelligent system for spine surgery.

Men lose their Y chromosome as they age: Scientists thought it didn’t matter—but now we’re learning more

February 13, 2026

New techniques to detect Y chromosome genes show frequent loss of the Y in tissues of older men.

Microfluidic chip finds viable eggs for IVF that doctors may have missed

February 13, 2026

Scientists have now developed a way to find missing eggs that could bring new hope to couples seeking fertility treatment.

Encora wins FDA clearance for wearable device for essential tremor

February 12, 2026

Encora Therapeutics announced today that it received FDA 510(k) clearance for its Encora X1 device.

Novocure wins FDA nod for Optune Pax as pancreatic cancer treatment

February 12, 2026

Novocure (Nasdaq:NVCR) announced that the FDA granted approval for its Optune Pax treatment for advanced pancreatic cancer.

Explant Express® Receives FDA 510(k) Clearance for Breast Implant Suction Retrieval Device

February 12, 2026

BRECKSVILLE, Ohio, Feb. 12, 2026 /PRNewswire/ — Applied Medical Technology, Inc. (AMT) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Explant Express®, a breast implant removal device designed to support efficient, controlled explantation of ruptured silicone breast implants.

Non-contractile heart cells help sustain persistent atrial fibrillation, study reveals

February 12, 2026

A multidisciplinary study led by the Centro Nacional de Investigaciones Cardiovasculares Carlos III (CNIC) and published in Circulation Research provides a new perspective on why this arrhythmia can persist long-term, highlighting the key role of non-contractile cardiac cells.

Blog

- Andrew Celentano

EYE PCR Receives CE Mark for fixOflex Endocapsular Device, Enabling European Market Introduction

InVera Medical Achieves European CE Mark Approval for New Vein Infusion Device

World-First EXO 001 Exosome Platform Enables In Vivo Multi-Target CAR-T for Solid Tumors

Medtronic receives FDA clearance for Stealth AXiS™ surgical system, first integrated planning, navigation and robotics platform for spine surgery

Men lose their Y chromosome as they age: Scientists thought it didn’t matter—but now we’re learning more

Microfluidic chip finds viable eggs for IVF that doctors may have missed

Encora wins FDA clearance for wearable device for essential tremor

Novocure wins FDA nod for Optune Pax as pancreatic cancer treatment

Explant Express® Receives FDA 510(k) Clearance for Breast Implant Suction Retrieval Device

Non-contractile heart cells help sustain persistent atrial fibrillation, study reveals