In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction summary reports for certain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) on Friday released a proposal that would allow medical device manufacturers to submit malfunction reports for certain devices to the agency in summary format ...

The U.S. Food & Drug Administration has issued an urgent medical device correction. Specifically, an error on the t:slim X2 insulin pump has been stopping insulin ...

Spread the love“`html Bluetooth technology has transformed the way we connect devices, making it easier to sync our smartphones, tablets, and laptops with various peripherals like keyboards, mice, and ...

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 ...

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 ...

A Bonita Springs resident and former chief operating officer of Magellan Diagnositics Inc. pleaded guilty to concealing a device malfunction that tests lead levels in children and others, according to ...