Catheter tips came off three damaged devices during surgery but none of the patients suffered serious injuries or died.

Regulation of lab developed tests returns to its status before the agency attempted to expand its jurisdiction and industry ...

AdvaMed welcomed the committee’s work on the legislation but called for the inclusion of diagnostics in the bill.

J&J’s Shockwave Javelin intravascular lithotripsy catheter treats people with peripheral artery disease. Elsewhere, Medtronic ...

Many of these devices currently sold over-the-counter do not have marketing authorization, the agency said in a notice.

Some firms, such as Aidoc, are working directly with the FDA. Others, such as HOPPR, are offering their foundation models for ...

The companies will develop a robotic system to improve patient outcomes in complex hemorrhagic cases and time-sensitive ...

Flavia Pease will take over as Insulet’s CFO on Sept. 30. Elsewhere, outgoing Dexcom CEO Kevin Sayer is taking a medical ...

The acquisition gives B. Braun control of a company that provides technology for its Aeos robotic digital microscope.

BTIG analysts said Senseonics is doubling down on its belief an inflection point in patient demand is imminent, but the ...

The deal includes AI-powered software for detecting known side effects of recently launched Alzheimer’s drugs.

BTIG analysts estimate that Elutia’s Elupro and Medtronic’s TYRX are competing for a $600 million opportunity in the U.S.