As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

With the consistent development of new apps, wearable devices are playing a growing role in monitoring our overall health.

Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...

The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology. By Christina Jewett There are now artificial intelligence ...

By Andrew Higgins The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology. By Christina Jewett ...

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory ...

Thanks to the implementation of Artificial Intelligence, it is now possible to analyze the ... such as wearables, smart sensors, and medical devices that integrate advanced functionality. Broadcom ...

Examples range from ambient voice transcription tools that enable doctors or nurses to spend more time with their patients to diagnostic devices ... be seen how medical professionals and patients will ...

has said it will launch a pilot programme in the coming weeks to see how it can evolve the regulation of artificial intelligence as a medical device (AIaMD) technology. The AI-Airlock regulatory ...

Despite an increase in profit margins in the quarter, Philips expects sales growth of 0.5% to 1.5%, down from 3% to 5% for ...

People often possess an array of devices that incorporate artificial intelligence ... There are currently no medical tests to definitively diagnose autism, but a recent study demonstrated that ...