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

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 ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are having greater impacts on the smallest patients—including in neonatal ...

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 ...

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 ...