New AEGIS framework enables safe continuous updates to medical AI systems under FDA and EU regulations without repeated approvals.

AEGIS operationalizes FDA's Predetermined Change Control Plan (PCCP) and EU AI Act Article 43(4) to govern iterative medical device AI model updates

Framework uses three modules: dataset assimilation/retraining, model monitoring, and conditional decision-making to maintain safety while enabling improvement

Introduces four-category deployment taxonomy (APPROVE, CONDITIONAL APPROVAL, CLINICAL REVIEW, REJECT) with independent Post-Market Surveillance alarm for detecting critical failures