360Dx

Lex Dx Wins FDA 510(k) Clearance, CLIA Waiver for Point-of-Care PCR System, Respiratory Test

NEW YORK – Lex Diagnostics said on Monday that it has obtained 510 (k) clearance and CLIA waiver from the US Food and Drug Administration for its Velo point-of-care molecular diagnostic system and an ...
Pharmabiz

LEX Diagnostics receives US FDA 510(k) clearance and CLIA waiver for LEX VELO system

LEX Diagnostics receives US FDA 510(k) clearance and CLIA waiver for LEX VELO system: Cambridgeshire, UK Tuesday, February 17, 2026, 17:00 Hrs [IST] LEX Diagnostics, a leading inn ...

Oral HIV self-test approved for sale, advocates say it's key to elimination

An oral, at-home HIV test that delivers results in as little as 20 minutes and has been used in the U.S. for well over a ...
Healthcare in Europe

Predicting neonatal sepsis with vaginal microbial swabs

Metagenomic analysis of vaginal microbiota at delivery outperforms traditional screening methods in identifying newborns at ...

QuidelOrtho Q4 Earnings Call Highlights

QuidelOrtho (NASDAQ:QDEL) management highlighted cost savings progress, steady underlying demand in its core Labs business, ...

QuidelOrtho Corporation (NASDAQ:QDEL) Q4 2025 earnings call transcript

QuidelOrtho Corporation (NASDAQ:QDEL) Q4 2025 Earnings Call Transcript February 11, 2026 QuidelOrtho Corporation beats earnings expectations. Reported EPS is $0.46, expectations were $0.43. Operator: ...