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.

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

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

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

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

Dexcom received FDA clearance in March for the first over-the-counter glucose monitor, called Stelo. It’s cleared for adults who don’t take insulin, including people with Type 2 diabetes. The wellness ...

The company collaborated with Zimmer Biomet on its Persona IQ device, which is slated for a full market release this year. Canary is also working on an implantable monitor for heart failure patients.

Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety complaints were listed that BD didn’t report within the required timeframe.