FDA Issues First Approval for SARS-CoV-2 Breathalyzer Test
InspectIR COVID-19 device detects the virus from breath samples in less than three minutes, offering a new screening option.
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FDA Lays Out New Guidelines for Medical Device Cybersecurity
With cyberattacks becoming increasingly common, the FDA has issued long-awaited draft guidance to help device makers deal with the threat.
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NIPS Tests Are under Fire Again—This Time from the FDA
With increasing media coverage about problems with genetic non-invasive prenatal screening, the agency warns of risks of false results.
FDA Issues First Ever Approval for a COVID-19 Breathalyzer
The FDA announced that, for the first time, it has granted Emergency Use Authorization for a COVID-19 breathalyzer test.
Congress Looks to Beef up Agency’s Power to Withdraw Unproven AA Drugs
The House Energy and Commerce Committee is considering a pair of rival bills, one Democratic and one Republican, to reform the AA process.
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