Search results
FDA considers updating blood donation guidelines to keep nation’s supply safe from malaria
CNN via Yahoo News· 58 minutes agoThe US Food and Drug Administration is considering a requirement for blood banks to use a new test...
FDA urges providers to ‘transition away’ from Getinge cardiovascular life support pumps
FierceBiotech· 7 hours agoFollowing 12 company recalls and nearly 3,000 reported issues related to its cardiovascular life...
FDA Releases New Draft Guidance Regarding Clinical Trial Data Monitoring Committees | JD Supra
JD Supra· 17 hours agoThe U.S. Food & Drug Administration (FDA) released a new proposed draft guidance in February that would change the FDA’s outlook on the engagement of a ...
US FDA advises healthcare facilities to switch from Getinge's heart devices
Reuters· 8 hours ago, opens new tab heart devices in patients as they faced safety and quality concerns despite a string...
FDA elevates Tandem Diabetes Care’s iPhone app recall, after glitches drained insulin pump batteries
FierceBiotech· 8 hours agoThe FDA is alerting users and providers to Tandem Diabetes Care’s recall of its insulin...
FDA issues recall statement after insulin pump-related IOS app causes injuries
NBC NEWS· 8 hours agoThe FDA has issued a statement following the Class I recall for an IOS app used in conjunction with...
FDA Recalls Defective iOS App That Injured Over 200 Insulin Pump Users - Slashdot
Slashdot· 1 hour agoOn Wednesday, the agency announced that California-based medical device manufacturer Tandem Diabetes Care has issued a recall for version 2.7 of the iOS t:connect mobile app, which is used in ...
FDA’s Final LDT Rule Is Here, and the Changes Show the Agency Is Serious and Actually Listening to...
The National Law Review· 3 days agoThe Food and Drug Administration (FDA) published its final rule on laboratory developed tests (LDTs)...
FDA Issues Final Guidance to Clarify "Remanufacturing" of Devices that Need Maintenance or Repair
WFRV 5 Green Bay· 10 hours ago"Today's action represents an important step forward in our mission to assure continued patient access to high-quality, safe and effective medical devices," said Jeff Shuren, M.D., J.D., director ...
Over 200 People with Diabetes Injured After Insulin Pump App Crashes, Drains Battery
People via Yahoo News· 4 hours agoThe FDA has issued a recall for the t:connect app, which connects via Bluetooth to insulin pumps...