Healio

Standalone reader for FreeStyle Libre 3 CGM receives FDA clearance

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. The FDA granted clearance for a standalone reader to be ...
Nasdaq

Abbott (ABT) Gets FDA Clearance for FreeStyle Libre 3 Reader

Abbott Laboratories ABT recently announced the FDA clearance of a standalone reader for its FreeStyle Libre 3 integrated continuous glucose monitoring system (iCGM). Through the reader, diabetes ...
FierceBiotech

FDA clears Abbott's hand-held diabetes reader for FreeStyle Libre 3 CGM

As it embarks on a widespread effort to remind users of the proper care and keeping of the hand-held readers used with its FreeStyle Libre continuous glucose monitors, Abbott is further expanding the ...

Seven deaths linked to malfunctioning glucose monitors

Some FreeStyle Libre 3 glucose sensors made by Abbott Diabetes Care may give incorrect low readings. The devices have been ...
BioWorld

Abbott freed to pursue CMS coverage with Freestyle Libre 3 reader clearance

Abbott Laboratories Inc. landed U.S. FDA clearance for its Freestyle Libre 3 integrated continuous glucose monitoring system (CGM)’s reader device a bit earlier than expected. With the regulatory ...
WFTV

FDA issues ‘early alert’ over FreeStyle Libre 3 sensors

The Food and Drug Administration issued an “early alert” concerning FreeStyle Libre 3 and FreeStyle Libre Plus sensors used by people who have diabetes. The agency said Abbott Diabetes Care has sent a ...

3 million diabetes glucose monitors recalled after 7 deaths and over 700 injuries

Abbott Diabetes Care has recalled certain glucose monitoring sensors after reports of seven deaths and more than 700 injuries possibly linked to malfunctioning devices that could provide inaccurate ...

FDA issues alert for faulty glucose monitors linked to 7 deaths: List of brands

The issue affected about 3 million Libre 3 and Libre 3 Plus sensors in the U.S. and globally Abbott has received reports of 736 serious health problems (57 in the U.S.) and seven deaths (none in the U ...

Diabetes Glucose Monitors Recalled After 7 Deaths and More Than 700 Injuries

Abbott Diabetes Care is warning patients to stop using certain glucose monitors that have been recalled following the deaths of seven people.
MD&M East

Abbott Recall Small Number of FreeStyle Libre 3 Sensors

Abbott Laboratories has initiated a voluntary recall of a small number of FreeStyle Libre 3 sensors within three lots distributed throughout the US. Designed to be what the company says is the world’s ...
Healio

Voluntary medical device correction issued for small subset of FreeStyle Libre 3 sensors

We were unable to process your request. Please try again later. If you continue to have this issue please contact [email protected]. Abbott issued a medical device correction for some ...