The flow of data within a product lifecycle ... skills required to contribute to the development of a new medical device in an industrial setting. The module covers EU and FDA medical device ...

With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

Olympus advised providers to stop using an endoscope accessory due to an infection risk linked to 120 injuries and one death.

In a new analysis of AI and ML-enabled devices authorized by the Food and Drug Administration, Brewster and colleagues at Boston Children’s and Harvard Medical School found just that.

Kolaleh Eskandanian, chief innovation officer at Children’s National Hospital, said the partnership is meant to address the ...

EBR Systems, Inc. Shs Chess Depository Interests Repr 1 Sh ( (AU:EBR) ) has issued an update.

Plus, the FDA issues final guidance for makers of AI-enabled medical devices so they can now update their software after approval. And it was a good year for health tech startups — after a not-s ...

With the White House set to change hands, nearly 200 advocacy groups are calling on the Food and Drug Administration to finalize a ban on the use of devices that administer electric shocks to address ...

Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory ...

When Eagle visited the Judge Rotenberg Educational Center in a suburb south of Boston, with her mother in the early 2000s, the 13-year-old stepped into the brick building and caught a bizarre ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from ... are listed below. Use the chart below to view import alerts. Click here to go to ...