Shots:
The US FDA has received 510(k) clearance & CLIA waiver application of VELO system for highly sensitive PCR results for respiratory pathogens
LEX Diagnostics has completed US trials of the VELO system & Influenza/COVID assay during the 2024/2025 season & expects 510(k) clearance by late 2025 or early 2026, pending FDA review
VELO system…
