In a new draft guidance issued on Thursday, the US Food and Drug Administration (FDA) aims to clarify how manufacturers can voluntarily submit malfunction summary reports for certain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 ...

Boston Scientific (NYSE:BSX) has initiated a nationwide recall of its Orca Single Use Air/Water and Suction Valves. The ...

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 ...

Tandem Diabetes Care issued an urgent medical device correction to upgrade the software of its Tandem Mobi insulin pumps that can fail to deliver critical medicine to patients. (Getty Images) Tandem ...

Medical device manufacturer Zoll was given a warning letter by the U.S. Food and Drug Administration for violations of ...

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 ...

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 ...

FDA has issued an early alert related to a bloodline set for hemodialysis systems that is malfunctioning because of a change in the plastic resin used to fabricate the tubing. FDA said in the alert ...

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 ...