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fda
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·9 min read
Clinical AI Decision Support 2026: FDA January Guidance, Non-Device CDS Criteria, and Human Oversight Requirements
Check FDA's four-factor test to see if your clinical AI decision support tool is exempt Non-Device CDS or regulated SaMD under the January 2026 guidance.
·10 min read
FDA AI Medical Device Compliance 2026: SaMD Classification, 510(k), and Predetermined Change Control Plans
1,350+ AI medical devices are FDA-cleared. Which SaMD class, 510(k) or PMA pathway, and PCCP rules govern your 2026 compliance plan?
·9 min read
Midjourney's 60-Second Body Scanner Claims to Beat MRI. Here's What FDA Clearance Actually Requires.
One word keeps Midjourney's 60-second scanner out of FDA AI medical device clearance in 2026. Here's what the SaMD pathway actually requires.