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If authorized, the test will be integrated into the company’s telehealth program — Cue Care —which enables users who test positive to seek prescribed COVID-19 treatment from a physician online. Read More
“For the time being, Lumos does not intend to further invest in activities directed towards securing U.S. clearance for FebriDx,” the company said. Read More
The FDA has extended the comment period for its draft guidance on LASIK devices by 30 days in response to multiple requests by device groups. Read More
General Physiotherapy was hit with a Form 483 after an FDA investigator observed product testing and other quality deficiencies at the company’s Earth City, Mo., facility. Read More
Within days of the reauthorization by Congress of the FDA’s user fee programs for the next five years, the agency posted its fiscal 2023 device user fees – increasing most of them by a hefty 18 percent and a couple by more than 50 percent. Read More
The FDA offers advice on postmarket surveillance and postapproval studies for moderate and high-risk devices in two final guidance documents released yesterday. Read More