LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Shots: The US FDA has granted 510(k) clearance & CLIA waiver to 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 respiratory season, with US commercial activities anticipated in 2026 VELO system allows multiplex PCR testing for respiratory…

ByRidhi RastogiFebruary 16, 2026

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Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

Shots: The US FDA has granted 510(k) clearance to cobas Respiratory 4-flex, which utilizes TAGS technology for simplification of respiratory testing & improving diagnostic speed as well as accuracy The cobas Respiratory 4-flex integrates seamlessly with cobas 5800, 6800 & 8800 systems to allow qualitative detection & differentiation of SARS-CoV-2, influenza A/B, as well as…

ByDipanshu DixitAugust 7, 2025

LEX Diagnostics Receives 510(k) Clearance and CLIA Waiver Status for its VELO System to Deliver Highly Sensitive PCR Results

Roche Receives the US FDA’s 510(k) Clearance for cobas Respiratory 4-flex for Comprehensive Respiratory Pathogen Detection

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