During the company's fourth-quarter earnings call Thursday, Arduini said the company has no plans to slow down. During the ...

Increasing medical device sophistication relates to the inclusion of more connectivity and advanced features like artificial intelligence (AI ... principal analyst, strategic research at GlobalData, ...

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 ...

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 ...

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 ...

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 ...