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

Vulnerabilities in certain Contec and Epsimed patient monitors can allow people to gain access and potentially manipulate the ...

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 ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

PLUS: MGM settles breach suits; AWS doesn't trust you with security defaults; A new .NET backdoor; and more Infosec in brief ...

The future of medical devices has much potential, but they also have risks related to cybersecurity. In 2024, we saw the first full year of the Food and Drug Administration’s (FDA) new guidance ...

The FDA says the cybersecurity vulnerabilities identified may put patients at risk when the device is connected to the internet.

The guidance discusses "how and when, in marketing submissions, sponsors should describe the postmarket performance monitoring and management of their AI-enabled devices," an FDA news release states.

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 ...

Guidance Shares Strategies to Address Transparency and Bias, while Providing Key Considerations and Recommendations on Product Design, Development and Documentation "The FDA has authorized more ...

Troy Tazbaz, director of the FDA’s Digital Health Center of Excellence, said the agency has authorized more than 1,000 AI-enabled devices to date. “As we continue to see exciting ...