CHICAGO, Feb. 19, 2026 /PRNewswire/ — Sibel Health, a leader in medical-grade wearable sensor technology, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s recent Letter of Intent (LOI) into the Clinical Outcome Assessment (COA) Qualification Program under the Drug Development Tool (DDT) framework. The acceptance marks a significant milestone in advancing objective cough frequency measurement for adult patients with chronic refractory cough (CRC) using a novel Cough Monitoring sensor, the Aria sensor.

NG Biotech manufactured the assays in France, with Hardy Diagnostics serving as the exclusive distributor in the US.

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”).

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.

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.