Keyword: Food and Drug Administration (FDA)

Eko's AI could allow a broader number of physicians to digitally screen patients for heart murmurs without needing a trained cardiologist.

Fierce 15 winner MaxQ AI received an FDA clearance for its artificial intelligence software that rapidly detects brain bleeds in CT scans.

The FDA approved Ortho’s Vitros fourth-generation HIV combination test, which detects HIV-1 and HIV-2 antibodies and the p24 antigen.

An FDA advisory committee voted 17-1 on Friday to recommend the approval of Sage Therapeutics’ postpartum depression drug, brexanolone.

The FDA has declined to approve Trevena’s oliceridine three weeks after an FDA advisory committee voted narrowly against the drug’s approval.

The FDA has slapped a Class I recall, its most serious and highest recall alert, for strips sold by Roche Diagnostics that are used to check warfarin levels.

An FDA advisory committee voted 21-2 against recommending the drug for approval, teeing it up for a likely rejection come January.

23andMe's test is approved to detect 33 variants of multiple genes to provide information about how a person metabolizes some medications.

NeuroPointDX has launched what it says is the first objective blood test set up to help diagnose children with autism spectrum disorder earlier.

Axonics Modulation Technologies has pulled in a meaty IPO as it looks to compete with medical technology major Medtronic.