Loading…
Tag
medical-device
2 posts with this tag.
Other tags:All postsacceptable-useacceptable-use-policyaccess-controlaccountabilityadministrative penaltiesAdobe FireflyadtechAfrican musicage gatingagent oversightagentic-aiai-acceptable-useai-adoptionAI Agent Safetyai-agentsai-apis
·10 min read
FDA AI Medical Device Compliance 2026: SaMD Classification, 510(k), and Predetermined Change Control Plans
FDA has authorized more than 1,350 AI-enabled medical devices as of early 2026. The framework covers classification (Class I, II, III), the 510(k) vs PMA pathway, Good Machine Learning Practices, and Predetermined Change Control Plans for AI systems that update after clearance. A compliance guide for healthcare AI developers and deployers.
·9 min read
Midjourney's 60-Second Body Scanner Claims to Beat MRI. Here's What FDA Clearance Actually Requires.
Midjourney announced a full-body ultrasonic scanner in June 2026, 60x faster and 10x cheaper than MRI, it claims. But it deliberately avoids diagnostic claims because those trigger FDA medical device clearance. Here is what the SaMD pathway requires, why the regulatory gate exists, and what it means for every team using AI tools that touch patient data.