Search results
United Imaging secures FDA clearance for uMR Jupiter 5T MRI system
Medical Device Network via Yahoo Finance· 20 hours agoUnited Imaging, a medical imaging and radiotherapy equipment maker, has secured the US Food and Drug...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI· 19 hours agoMost of the drug overdoses are caused by opioids or fentanyl. In a move that health experts say may...
Continued FDA testing finds no active bird flu virus in variety of dairy products
WKBT La Crosse· 1 day agoThe FDA has tested samples of fluid milk and other kinds of products made from milk, like cheese and...
FDA qualifies Apple Watch’s AFib history for use in clinical studies
The Verge· 13 hours agoApple has long touted its watch as a lifesaver for those who wear one. Features such as fall...
FDA Makes Good on Its Promise to Regulate Laboratory-Developed Tests
The National Law Review· 2 days agoYesterday, the Food & Drug Administration (“FDA” or “the Agency”) issued a highly anticipated – and...
FDA issues final rule regulating LDTs as medical devices
Medical Device Network via Yahoo Finance· 3 days agoThe FDA ruling follows years of industry back and forth and sees the government body choosing to...
FDA Issues Much-Anticipated Final Rule on Laboratory Developed Tests | JD Supra
JD Supra· 23 hours agoThe final rule amends FDA regulations to make it explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act, including when the manufacturer of the IVD ...
FDA finalizes lab test regulations with more flexibility
Politico· 3 days agoThe new requirements, which kick in over the next four years, include a handful of substantial changes from the agency’s initial proposal. Chief among them is a grandfathering clause which means ...
FDA finds no live H5N1 avian flu virus in sour cream or cottage cheese, will assess raw milk
Center for Infectious Disease Research and Policy· 1 day agoIn updates today from federal agencies involved in the response to H5N1 avian flu outbreaks in dairy...
FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
WPXI via Yahoo News· 1 day agoIn a move that health experts say may reduce the number of fentanyl deaths, the FDA has approved...