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

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

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 ...

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

Johnson & Johnson, Medtronic and Abbott were among the top companies to announce layoffs this year as the industry implemented cost-cutting measures.

Boston Scientific has updated the instructions for its Polarx and Polarx FIT cryoablation balloon catheters, the Food and Drug Administration said Wednesday. The update followed a higher than expected ...