NG Biotech announces FDA approval for diagnostic assays
February 19, 2026
NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.
NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.
Medtronic (NYSE: MDT)+ announced today that it received FDA premarket approval (PMA) for the use of its Infuse bone graft in TLIF procedures.
The system is intended for use in urgent care clinics, primary care settings, physician office laboratories, and pharmacies.
WESTFIELD, Ind., Feb. 17, 2026 /PRNewswire/ — Today, Portal Diabetes, Inc. (“Portal”) announced its receipt of the Breakthrough Device Designation by the Food and Drug Administration (FDA) for its implantable insulin pump system called “Portal Pump,” and the start of a Phase 1 study on its proprietary temperature-stable insulin (“Portal Insulin”).
WHITE PLAINS, N.Y., Feb. 17, 2026 /PRNewswire/ — Retia Medical today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Argos Infinity™, the company’s cardiovascular intelligence software platform designed for high-risk surgical and critical care environments across health systems.
MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ — Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with WASPLab® full laboratory automation, received FDA 510(k) clearance as a Class II device in the United States.
Winning approval to target the 15,000 U.S. patients with locally advanced pancreatic cancer is the first step in a broader expansion in the tumor type.
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.
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.
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.