Danaher subsidiary Beckman Coulter Life Sciences announced Tuesday that its DxFlex Clinical Flow Cytometer has received 510(k) clearance from the US Food and Drug Administration.

DiaSorin has received the US Food and Drug Administration’s 510(k) clearance for its LIAISON PLEX platform and the accompanying LIAISON PLEX Respiratory flex assay.

The US Food and Drug Administration last week granted Emergency Use Authorizations for two point-of-care COVID-19 and influenza combination tests developed by Sekisui Diagnostics.

French diagnostics firm Sebia said Thursday that it has received US Food and Drug Administration 510(k) clearance for its FLC Kappa and Lambda assays.

EnsoData has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine learning-based diagnostic for sleep apnea and other sleep disorders that uses data from pulse oximetry (pulse ox) devices.

The US Food and Drug Administration on Tuesday issued a letter to medical device manufacturers and sponsors of device studies warning them to independently verify performance test results before submitting them to the agency due to concerns about fraudulent results.

The US Food and Drug Administration said on Wednesday that its Center for Devices and Radiological Health (CDRH) is planning a process to reclassify some high-risk in vitro diagnostics as moderate risk in a move that the agency said would allow manufacturers to seek marketing clearance for their tests through a less stringent regulatory pathway.

DiaSorin on Thursday said it has submitted for US Food and Drug Administration approval an immunoassay for the early identification of Lyme disease.

Cepheid announced today that it has received FDA Clearance with Clinical Laboratory Improvement Amendments (CLIA) waiver for Xpert® Xpress MVP. This multiplex vaginal panel can now be performed in near-patient settings, enabling results within 60 minutes from a single specimen for Bacterial Vaginosis (BV), Vulvovaginal Candidiasis (VVC), and Trichomoniasis (TV). This expanded claim exemplifies Cepheid's commitment to providing expanded access to women's and sexual health by making PCR testing accessible at the point of care. The test runs on Cepheid's GeneXpert Xpress instruments and has been approved for testing women fourteen years of age and older.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.