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

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

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.

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

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

The continuing resolution would fund the government, and preserve the flexibilities, through Nov. 21. But the bill makes no mention of extending more generous financial assistance for people who buy ...

BD, which has not received any complaints related to the issue, previously discontinued the devices affected by the expanded ...

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

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 ...

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