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

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

FDA unveiled an Idea Lab as part of its Home as a Health Care Hub initiative to reimagine how new and existing medical ...

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

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

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Too many alarms on the AquaFlexFlow UF 500 Plus could terminate therapy, leading to hypovolemia or dehydration.

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.

FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but two lawsuits over the final rule ...

South Florida's health care industry made headlines in 2024, with medical device and pharmaceutical companies announcing ...

The FDA has expanded the approval of Eli Lilly’s obesity medication Zepbound to include treating moderate to severe ...