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

The medical device sector faces significant changes, as both Donald Trump and Robert F. Kennedy Jr. have identified the FDA ...

The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F ...

The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed ...

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

“We are very excited to receive FDA clearance ... best-in-class respiratory therapy devices used to deliver care to patients suffering from chronic respiratory conditions. Inogen partners with ...

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

South Korea’s Ministry of Food and Drug Safety cleared Acryl Inc.’s Acryl-D01 as the country’s first AI-based digital ...

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 ...

A novel nanobody-based immunosensor, designed to function stably in undiluted biological fluids and harsh conditions, has been developed. Their innovative design leverages BRET -- bioluminescence ...

New collagen-based dermal matrix designed for tissue generation, complementary to RECELL and PermeaDermCohealyx expected to triple AVITA ...