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.

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

Improper or incomplete reprocessing of the MAJ-891 forceps/irrigation plug has led to reports of patient infections.

Shares in the company were up 7% at market open following the first approval for a non-invasive spinal cord stimulator for ...

This week, the FDA issued recommendations for streamlining the clearance process for AI-powered medical devices. The memo announcing this change recognizes that the utilization of AI in devices ...

The Food and Drug Administration issued a much-anticipated update on Tuesday detailing how it plans to regulate changes to artificial intelligence-enabled medical devices after the agency has ...

While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...

In international markets, the RECELL System is approved to promote skin healing in a wide range of applications including burns, full-thickness skin defects, and vitiligo. The RECELL System, excluding ...