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 ...

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

IPOs in medtech have been sparse, but some analysts said improving market conditions could support a revival of offerings in ...

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

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

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

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

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

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 ...

Industry and patient representatives debated how the FDA should regulate generative AI in medical devices and address new ...