In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction summary reports for certain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 ...
The US Food and Drug Administration (FDA) has finalized guidance on submitting voluntary malfunction summary reports for certain class I and class II lower-risk devices. The guidance is almost ...
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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 devices 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 that ...
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Diabetes warning issued over insulin pump error
A medical device manufacturer has issued an urgent correction for select insulin pumps due to a possible error that could result in insulin not being delivered, the U ...
The US Food and Drug Administration today issued an early alert to warn of the possibility that the differential pressure sensor can malfunction in Impella RP with SmartAssist and Impella RP Flex with ...
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 ...
Three former executives at Magellan Diagnostics have pleaded guilty to concealing a device malfunction that led to inaccurate lead level tests in thousands of patients, many of them children. The ...
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