The FDA released Monday two guidance documents targeting the use of artificial intelligence in drug and medical device development, its latest effort to ensure safety and efficacy in the products it regulates amid rapid growth of the technology.
Medical device manufacturers received a draft guidance on agency recommendations regarding marketing submissions for AI-enabled devices that will support the Food and Drug Administration’s evaluation of safety and effectiveness.
AI-enabled medical devices, which derive new data and insights as they’re used, provide an array of services, such as diagnosing patients, detecting diseases at early stages, or providing measurements of clinical images. The ...
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