Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...

The update followed a higher than expected number of reports of esophageal injury after catheter ablation procedures for ...

Industry experts said profit pressures and M&A contributed to job cuts. They said layoffs will likely continue into next year ...

Pulsed field ablation could soon be used in the majority of electrophysiology procedures to treat atrial fibrillation as ...

Edwards submitted a request for a national coverage determination in February, after receiving FDA approval for its Evoque ...

Joseph Wright’s resignation is effective in January, and CEO and founder Fred Lampropoulos has been reappointed president.

Sometimes the most under-hyped sectors are the best places to build very large businesses,” said one venture investor who ...

From challenging market leaders to the growing influence of artificial intelligence, medical device executives had a lot to ...

Just in time for the holiday season, ZuriMED Technologies AG celebrated a significant achievement: FDA clearance of their 510 ...

With about one month before inauguration day, check out a roundup of MedTech Dive’s coverage on what President-elect Donald ...

Dexcom this week began rolling out the feature, which analyzes data to provide personalized tips and recommendations.

Bumpus replaced agency veteran Janet Woodcock as principal deputy commissioner in February 2024. She was previously the FDA’s ...