FDA-Cleared AI Achieves Neurologist-Level Neuroimaging Accuracy
#1FDA-cleared AI imaging analysis tools have crossed the clinical equivalence threshold for the highest-volume neuroimaging tasks in neurology. Viz.ai, Aidoc, and RapidAI collectively process millions of neuroimaging studies annually in live clinical environments, not just research settings. The regulatory approval pipeline for expanded AI imaging indications is accelerating: the FDA cleared 521 AI/ML-based medical devices by 2023, with radiology/neurology comprising the largest single category, and the approval rate is increasing year-over-year.