Browsing: FDA

What You Should Know The Milestone: GE HealthCare has officially received FDA 510(k) clearance for Photonova Spectra, its highly anticipated…

MiniMed Flex is a smartphone-controlled insulin pump about half the size of MiniMed’s previous device. It’s the company’s first launch…

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Share on PinterestMore research is still needed before leucovorin should be approved as an autism treatment. Westend61/Getty ImagesFederal regulators have…

Dive Brief: The Food and Drug Administration on Wednesday launched a new system designed to allow the public, researchers and…

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What You Should Know: The Clearance: GE HealthCare has officially received FDA 510(k) clearance for View, a fast, zero-footprint diagnostic…

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration. In a…

Unomedical, a subsidiary of Convatec and a supplier of insulin infusion sets to diabetes tech firms, received a warning letter…

Dive Brief: Abbott has won approval for updated remote heart failure monitoring technology, the company said Friday. The Food and…