Abbott's Exact Sciences buy, Blackstone and TPG's Hologic acquisition, and Water's BD transaction could herald a busy 2026 ...

The Florida company's Kiffik K-Exp platform enables continuous access to interstitial fluid for longitudinal molecular diagnostic testing.

The SD Biosensor Standard Q COVID-19 Ag Test and Acon Biotech Flowflex SARS-CoV-2 Antigen Rapid Test were previously listed under WHO's emergency use listing.

Readers this past year were most interested in a story about the FDA abandoning its plans to regulate LDTs after a court struck down its efforts.

NEW YORK – Italian in vitro diagnostics firm Diasorin said on Sunday that the US Food and Drug Administration has issued 510(k) clearance and CLIA-waived the firm's first assay for use on the Liaison ...

Last week, readers were most interested in a story about concerns among some clinicians around BillionToOne's Unity NIPT due to false negative results.

NEW YORK - The US Food and Drug Administration granted 510(k) marketing clearances in November to Roche Molecular Systems, Cytovale, Truvian Health, and others for infectious disease pathogen ...

NEW YORK – Increased commercial alliances, regulatory clearances, and academic evaluations helped advance digital pathology into the mainstream in 2025 and toward further adoption in the coming years.