The Food and Drug Administration is requesting public comment to get feedback on current, practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real ...

The FDA’s call for feedback is informed by evidence that the performance of AI-enabled medical devices can change over time. As the agency explained in its request for comment, factors such as changes ...

Integrating AI into medical devices brings the industry a new level of innovation. The benefits can help both providers and patients but also introduce more risk. AI’s application in any technology is ...

Increased R&D investments to integrate AI on devices across disease states designed to boost productivity, efficiency, and diagnostic confidence for healthcare professionals, and drive the company’s ...

The American Hospital Association (AHA) is calling on the Food and Drug Administration (FDA) to develop evaluation standards and measurements to assess the impacts of medical tools that use artificial ...

Legal filings submitted earlier this month from lawyers representing OpenAI and Jony Ive’s io reveal new details about the companies’ efforts to build a mass-market AI hardware device. The filings are ...