The US Food and Drug Administration in May granted 510(k) clearances for tests and testing systems by Abbott, Hologic, and Becton Dickinson, among others.

Cue Health, a healthcare technology company, announces an industry breakthrough as the first company to receive De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Cue COVID-19 Molecular Test, designed for both home and point-of-care use.

Hologic Inc. (Nasdaq: HOLX) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay. This assay is a molecular diagnostic test that detects and differentiates four of the most prevalent respiratory viruses that can exhibit similar clinical symptoms: severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (flu A), influenza B (flu B) and respiratory syncytial virus (RSV).

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Thermo Scientific B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers, the first and only immunoassays to receive breakthrough designation and clearance for the risk assessment and clinical management of preeclampsia, a severe pregnancy complication.

On May 8, Singlera Genomics announced that its self-developed PDACatch test, a novel DNA methylation-based liquid biopsy test for detecting pancreatic cancer in high-risk populations, has been granted Breakthrough Medical Device designation by FDA.

BioMérieux announced on Tuesday that its BioFire SpotFire Respiratory Panel Mini has obtained CLIA wavier from the US Food and Drug Administration.

Meridian Bioscience said Wednesday the US Food and Drug Administration has cleared the firm's Curian Shiga Toxin immunoassay, expanding the firm's gastrointestinal disease product line.

BioMérieux said Friday it is seeking US Food and Drug Administration 510(k) clearance that would allow a US launch of its Vitek Reveal rapid antimicrobial susceptibility testing system to help guide treatment of bacterial sepsis.

Danaher subsidiary Leica Biosystems said Monday that it secured US Food and Drug Administration 510(k) clearance for its Bond MMR Antibody Panel to help identify potential Lynch syndrome in colorectal cancer patients.

The US Food and Drug Administration this week released its guidance document for developers of medical devices for COVID-19, including diagnostic tests, on how to transition from Emergency Use Authorization to full marketing and regulatory authorization.