FDA received 867 reports related to infections or device contamination associated with reusable flexible bronchoscopes between July 2015 and January 2021. The agency just updated its guidance for reprocessing these difficult-to-clean devices.

We need to adopt collaborative development strategies to collect real-world data and then use it as feedback to avoid racial bias in our medical device technologies.

A pilot program launched in 2018 to shift the mindset of medical device manufacturers beyond regulatory compliance and toward continuous quality improvement is now a fully operational program.

A medtech analyst frames ResMed's potential opportunity for market share gain in the wake of Philips' massive recall on sleep apnea devices.

Pressed for time? Here's the medtech news you need most, in one minute or less.

Marlborough, MA-based Hologic has announced four acquisitions this year. The company had more cash on hand than usual because of strong sales of COVID-19-related tests.

FDA seeks feedback on medical device content labeling.

The impetus behind the recall stems from the fact the foam used to dampen the machines’ sound can degrade and emit small particles that irritate airways.

FDA wants the public to stop using the Innova SARS-CoV-2 antigen rapid qualitative test for diagnostic use. The agency raised concerns about the performance of the test, which has not been authorized, cleared, or approved for the U.S. market. The...