Increasing medical device sophistication relates to the inclusion of more connectivity and advanced features like artificial ...

Regulatory bodies in the US, UK, and EU are making progress in defining and regulating AI/ML-enabled medical devices, with a focus on ensuring safety and efficacy. This evolving regulatory ...

The HHS has released a strategic plan that lays ... The plan — which covers AI in medical research, products like drugs and devices, healthcare delivery, social services and public health ...

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

Sponsors seeking approval for medical devices containing AI components should carefully evaluate FDA’s requirements and confirm that they can adequately address FDA’s concerns and requirements ...

The Food and Drug Administration wants the developers of medical devices that rely on artificial intelligence to disclose much more detail about how their devices were developed and tested ...

Philips is rapidly embracing artificial intelligence, incorporating the tools into many of its medical imaging systems. The company launched a new MRI scanner, which features a variety of AI tools ...

This can be in the form of a coronary implant, such as Elixir Medical’s DynamX bioadaptor, or an AI-driven device that analyses heart activity and adjusts treatment based on fluctuations.

FDA Medical Device Regulation Over the Use of AI in Clinical Trials As FDA noted in the JAMA article, artificial intelligence and machine learning (AI/ML) have many potential uses in clinical ...