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, ...

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

It specifies that by 2035, China expects to fully ensure the safety, efficacy, and accessibility of drugs and medical devices ...

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

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.

In a significant step toward ensuring global quality standards, Indian pharmaceutical, nutraceutical, and medical device ...

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

Explore the rapid growth of the Indian MedTech industry and the importance of FDA 510(k) clearance for global expansion.

One could be forgiven for feeling the same way about the current world of drug delivery devices, with an increasingly ...

The emergence of adaptive cardiac devices, especially those that utilise AI, is propelling the wider industry shift towards ...