Medical Device

Medical device, as used in this directory, covers AI-enabled products regulated as healthcare tools, such as diagnostic imaging software, clinical decision support systems, and patient monitoring algorithms. These products typically fall under strict pre-market review and post-market surveillance requirements, so an AI model change can trigger new regulatory obligations. For compliance teams, the key questions are how a product is classified, what evidence regulators require about performance and safety, and who is accountable when the software is updated or fails.

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ResearchGlobal2026-10-24

MAI-DxO Outperforms Physicians in Research, But Lacks Clinical Clearance

Microsoft AI published research in Science showing its MAI-DxO diagnostic system is 1.7 times more accurate than physicians on common emergency department cases. It is more than twice as accurate on complex cases from The New England Journal of Medicine. The system has no regulatory clearance for clinical use. The gap between research performance and deployment-ready validation is the central governance challenge.

MAI-DxO Microsoft AI healthcare governance clinical AI FDA medical device AI liability diagnostic AI