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

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

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 ...

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

Flavia Pease will take over as Insulet’s CFO on Sept. 30. Meanwhile, 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.

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

Three new software features for Intuitive’s most advanced soft tissue surgical robot have received 510(k) clearance from the ...

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

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