The FDA recently issued draft guidances ... finding applications across medical devices and pharmaceutical development. In medical devices, AI models power tools such as software that analyzes ...

The FDA has responded to the increasing use of artificial intelligence (AI) in the discovery and development of drugs ... medicinal product lifecycle. Medical device advice Meanwhile, the US ...

As medical devices become more complex, and as regulatory requirements become more rigorous, it’s imperative that medical devices using electronic components are developed as efficiently as possible.

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 ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

A new Supernus Pharmaceuticals medical device that continuously ... for the neurological disease wanes. The drug/device combination product, known in development as SPN-830, will be commercialized ...

The website changes raise concerns about “the interference of politics with the study and the practice” of science and medicine, one physician said.

This accomplishment comes only eight months after the FDA granted ... cases of device-related infections. OSTAGUARD is applied to a medical device surface during the manufacturing process prior ...

The FDA’s Breakthrough Device Designation is reserved ... expediting the development and commercialization process for PathChat DX. The designation highlights the FDA’s recognition of the ...