FDA: Device Delivers Non-invasive Therapy and Supports Care at Home White Oak, Md., Feb. 12, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration has approved a first-of-its-kind device for the treatment of adult patients with...

CDx Diagnostics: Novel AI-powered laboratory test for diagnosis of Barrett's esophagus, with or without dysplasia SUFFERN, N.Y., July 24, 2025 (Newswire.com) – CDx Diagnostics announced today that the U.S. Food and Drug Administration...

Boston - June 30, 2025  -  PathAI, a global leader in artificial intelligence (AI) and digital pathology solutions, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for AISight®...

[CORRECTED RELEASE] Updated to clarify reference to dual-scanner FDA clearance. PARIS, FRANCE / ACCESS Newswire / May 21, 2025 / Tribun Health, a leader in digital pathology, proudly announces that its flagship web-based image management...

The Roche VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment.  The device uses artificial intelligence-based image analysis with a...

Paige PanCancer Detect recognized by FDA as a Breakthrough Device intended to assist pathologists in the detection of cancer across multiple tissue and organ types NEW YORK--(BUSINESS WIRE)--Paige, a leader in next-generation AI...