Optiscan has lodged a US FDA 510(k) submission for its InVue precision surgery device InVue is designed to give surgeons real-time, cellular-level images of tissue while a patient remains in theatre The filing follows Optiscan’s...

PHILADELPHIA — August 6, 2026 — Proscia® has received a new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Concentriq® AP-Dx. The clearance includes compatibility with the Leica Aperio® GT 450 DX slide scanner,...

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...