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FDA Struggles to Keep Pace as Adaptive AI Medical Devices Start Learning After Clearance

Adaptive AI is exposing a regulatory gap: devices can keep changing after clearance, but the FDA’s review model still assumes a relatively fixed product. The result is a growing mismatch between how these tools are built and how they are overseen. The issue matters because adaptive systems could improve faster over time—or drift in ways that are harder to detect. Regulators, manufacturers, and hospitals are now confronting the question of how to monitor software that never really stops becoming something new.