FDA-Cleared AI Displacing Core Interpretive Tasks
#1Between 2021 and early 2026, the FDA cleared or authorized over 500 AI/ML-based medical devices, with a significant concentration in diagnostic imaging and neurological signal analysis — the exact interpretive domains where neurodiagnostic and ophthalmic technologists derive their professional value. Products like EyeArt (autonomous diabetic retinopathy detection), Ceribell Clarity (real-time seizure detection), Notal Vision HALO (autonomous AMD monitoring), and Persyst 14 (automated EEG analysis) are not screening aids — they produce final-grade diagnostic determinations that previously required credentialed human review. CMS reimbursement codes have been updated to accommodate AI-autonomous readings, removing the billing disincentive that previously slowed adoption.