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The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...
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 ...
Repeated training is essential for ensuring that the workers are abreast of the latest technologies, ranging from software development ... in the medical device manufacturing process.
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 partnership will leverage SonoBiopsy tech for early detection of toxic amyloid abnormalities linked to Alzheimer’s.
The FDA’s Breakthrough Device Programme is designed to accelerate the development and review of medical devices that ... potential for a faster approval process. Acceptance into the Tap ...
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 ...
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