Receiving a defective medical device can have major consequences. Serious infections, internal injuries, and the need for ...
The US Food and Drug Administration (FDA) on Friday released a proposal that would allow medical device manufacturers to submit malfunction reports for certain devices to the agency in summary format ...
In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction summary reports for certain medical devices ...
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Recall for medical device used by millions of Americans over malfunction that could lead to death
An urgent recall has gone out for a popular medical device used by millions of Americans with diabetes. The US Food and Drug Administration (FDA) has revealed that over two million blood glucose ...
Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps, which can fail to deliver critical medicine to patients. The software ...
SAN DIEGO--(BUSINESS WIRE)--Tandem Diabetes Care, Inc. (Nasdaq: TNDM) has announced a voluntary medical device correction for select t:slim X2 insulin pumps to ...
BOSTON — Three executives from a Billerica-based medical device company pleaded guilty in federal court this past week in connection with a malfunction in a series of lead testing devices prosecutors ...
Add Yahoo as a preferred source to see more of our stories on Google. A Bonita Springs resident and former chief operating officer of Magellan Diagnositics Inc. pleaded guilty to concealing a device ...
Ransomware attacks on the healthcare sector surged by 30 percent in 2025, frequently disrupting operational technology and medical devices. FDA Section 524B mandates that manufacturers provide a ...
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