Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

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 ...

The Food and Drug Administration is aiming to help developers of artificial intelligence-enabled medical devices understand the agency's mindset around the technology. The agency announced Monday ...

The US Food and Drug Administration (FDA) is cautioning patients and caregivers about the potential for not receiving blood ...

Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical ...

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but ...

Tazbaz was director of the FDA’s Digital Health Center of Excellence for two years, leading on policies involving artificial ...

Vitti Labs says the Food and Drug Administration erred in subjecting the lab's umbilical cord-derived product in a way that brings greater regulation. Liberty-based Vitti Labs, a human tissue bank ...

which typically are cheaper than FDA-cleared pulse oximeters and are sold over-the-counter. Some have criticized the lack of regulation for accuracy surrounding these devices. CEO John Hastings of ...