The new director of the FDA’s device center contrasted a European rule with the U.S.’s lack of mandatory reporting ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

“Our draft recommendations are based on the best available science to help address concerns of disparate performance of pulse ...

The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their ...

The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can ...

Problems with pulse oximeters have been known for decades, but it wasn’t until the pandemic that the real dangers to Black ...

The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...

There’s no better way to start the new year than with another season of Drag Race. This time, the 14 contestants can ...