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 ...

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

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

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

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Product approvals in regenerative medicine and rare diseases are among the highlights in our recap of recent FDA regulatory decisions.

The FDA on Friday approved Eli Lilly's weight-loss drug Zepbound as a treatment for moderate-to-severe sleep apnea and ...