Cue Health announced on Monday that it has received Emergency Use Authorization from the US Food and Drug Administration for its molecular monkeypox test.

Becton Dickinson announced that it received 510(k) clearance from the US Food and Drug Administration for a high-throughput assay to detect vaginitis.

Visby Medical said that it has received 510(k) clearance and a CLIA waiver from the US Food and Drug Administration for its second-generation point-of-care sexual health test.

QuidelOrtho Corporation, a global provider of innovative in vitro diagnostic technologies designed for point-of-care settings, clinical labs and transfusion medicine, announced today that it has been granted a De Novo request from the U.S. Food and Drug Administration (FDA).

Abbott announced on Tuesday that its laboratory-based test for traumatic brain injuries has received clearance from the US Food and Drug Administration.

Roche announced on Monday that its Ventana PD-L1 (SP263) assay has received approval from the US Food and Drug Administration for use as a companion diagnostic with Regeneron's Libtayo (cemiplimab) in lung cancer patients.

Recently, U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have released their summaries on medical device innovation in 2022.

The US Food and Drug Administration has allowed InBios International to market its point-of-care anthrax test, the firm announced this week.

Biocartis said Thursday that it has secured US Food and Drug Administration 510(k) clearance for a microsatellite instability (MSI) assay to screen for Lynch syndrome in colorectal cancer patients.

The $3.95 billion worldwide molecular diagnostic POC testing market is seeing increasing international activity with China becoming a particularly intriguing part of the Asia Pacific region according to The Market and Future Potential for Molecular Point of Care, published by Kalorama Information.