The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

A cutting-edge medical device which purifies and concentrates urine could be game-changing in the research and diagnosis of ...

Ageing patient populations and technological advancements are emerging as key drivers of healthcare innovation and delivery.

Europe medical device market was valued at $144.4 billion in 2022 and will grow by 4.7% annually over 2022-2032, driven by the prevalence of infectious diseases as well as the increasing prevalence of ...

Global medical device market will reach $882.3 billion by 2032, growing by 5.5% annually over 2022-2032 owing to aging population worldwide, the prevalence of infectious diseases as well as the ...

Many AI-enabled medtech products leverage machine learning or deep learning. In order to address the opaque decision-making ...

The growing internet of medical things (IoMT) has unique definitions and testing requirements.

Sign up for our Newsletters Inside a massive 450,000-square-foot manufacturing and testing facility in Bedford, about 1,100 engineers, scientists, software specialists and product support staff are ...

As medical devices become more complex, and as regulatory requirements become more rigorous, it’s imperative that medical devices using electronic components are developed as efficiently as possible.

KFDA sets global standard for generative AI medical device approval guidelines Health authority introduces pioneering ...

The millions of people residing in urban, semi-urban, rural, and remote areas, the lack of adequate healthcare infrastructure ...