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 ...

The payment resolves allegations brought by the Department of Justice that Exactech violated the False Claims Act by selling knee implants with components that failed prematurely.

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

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

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

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

The AI models, which are built on massive datasets and can be adapted to multiple tasks, have become a part of medtech ...

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

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

A two-day meeting could prove an inflection point in HHS Secretary’s Kennedy’s efforts to overhaul U.S. vaccine policy, as ...

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