What is the FDA’s approach to regulating AI/ML in Software as a Medical Device

 “SaMD” even reaches as far back as the 60s with Lockheed’s consideration of getting the first computerized information-handling system in the hospital sphere.

And do we know who the first company was to be approved by the FDA as a SaMD? I’m sure there was a hybrid that led up to that, and my guess is it’s archived somewhere, but my research didn’t come up with a specific name, but rather several SaMD firsts. Read more.

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