LEX Diagnostics Submits Dual Applications for FDA 510(k) Clearance and CLIA Waiver for Groundbreaking LEX VELO System

CAMBRIDGESHIRE, United Kingdom, June 06, 2025 (GLOBE NEWSWIRE) -- LEX Diagnostics, a leading innovator in molecular diagnostics, has submitted dual applications to the U.S. Food and Drug Administration (FDA) seeking 510(k) clearance and CLIA waived status for its VELO system, an ultra-fast point-of-care molecular diagnostics platform designed to deliver highly sensitive PCR results for key respiratory pathogens directly from a swab sample in under ten minutes.1

More here:
LEX Diagnostics Submits Dual Applications for FDA 510(k) Clearance and CLIA Waiver for Groundbreaking LEX VELO System