The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

Stifel analyst Rick Wise said the financing, a combination of private stock placement and new loans, should help the dialysis ...

Stryker made several small deals last year but lacked a larger acquisition like its nearly $5 billion proposal for Inari ...

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

The FDA released the guidance in response to concerns that the devices are less accurate in people with darker skin ...

The agency issued the alert as part of a pilot to improve the timeliness of communications about actions it believes are ...

McKinsey data shows that over a 10-year period, supply chain shocks could cost a medical device company 38% of a typical year ...

Multibillion-dollar buyouts returned last year, led by Johnson & Johnson’s $13.1 billion acquisition of Shockwave Medical.

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

Officials commissioned the independent review in September in response to a study that found tampons may expose users to ...

Abbott and Dexcom settled all patent lawsuits related to continuous glucose monitors (CGMs). The two competitors, who lead ...

Stefan Kaufmann, former CEO of Tokyo-based Olympus, stepped down in October after the company investigated an allegation that ...