510(k)

FDA 510(k) Clearance Establishes Broad Intended Use for Copan’s PhenoMATRIX, Expanding Clinical Microbiology Capabilities

MURRIETA, Calif., Feb. 17, 2026 /PRNewswire/ -- Copan Group announced today that PhenoMATRIX®, its automated image assessment software used with…

3 weeks ago

LEX Diagnostics Receives FDA 510(k) Clearance and CLIA Waiver for LEX VELO System

Ultra-fast point-of-care molecular diagnostics platform for key respiratory pathogens delivers results in under ten minutes February 16, 2026 05:00 ET…

3 weeks ago

Respiree Secures Second FDA 510(k) Clearance, Expands Cardio-Respiratory Wearable to Home Use via 1Bio Connected Care Platform

HOUSTON and SINGAPORE, Aug. 05, 2025 (GLOBE NEWSWIRE) -- Respiree, a health tech company developing artificial intelligence (AI) platforms to…

7 months ago

Leo Cancer Care Receives FDA 510(k) Clearance for Marie – A Revolutionary Upright Radiotherapy Platform

MIDDLETON, Wis., July 29, 2025 /PRNewswire/ -- Leo Cancer Care, a leader in upright radiotherapy solutions, today announces that its flagship…

8 months ago