FDA-Cleared AI Directory
Neurology AI Cleared by the FDA
A short list, led by software cleared to help diagnose autism in young children.
Neurology has very few cleared AI products, and the ones here are unusual.
The pediatric autism diagnosis aid is the notable case. It does not read a scan. It works from caregiver answers, clinician input, and video, and it is cleared to help a primary care clinician reach a diagnosis rather than to hand one down.
The gap between how much attention neurology AI gets and how little of it is cleared is one of the wider gaps in healthcare AI right now.
Device Types in Neurology
The FDA sorts cleared AI into named device types. Each one has its own bar to clear, so the type tells you what the product is allowed to claim.
| Device type | What it is allowed to do | Cleared | Latest |
|---|---|---|---|
| Pediatric Autism Diagnosis Aid | Helps a primary care clinician reach an autism diagnosis in young children, using caregiver answers, clinician input and video. | 6 | March 5, 2026 |
Newest Neurology Clearances
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| EarliPoint Assessment | Earlitec Diagnostics | March 5, 2026 | K253442 |
| Canvas Dx | Cognoa, Inc. | April 11, 2025 | K243558 |
| EarliPoint System | Earlitec Diagnostics | March 26, 2025 | K243891 |
| EarliPoint | Earlitec Diagnostics, Inc. | June 29, 2023 | K230337 |
| EarliPoint System | Earlitec Diagnostics, Inc. | June 8, 2022 | K213882 |
| Cognoa ASD Diagnosis Aid | Cognoa, Inc. | June 2, 2021 | DEN200069 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance is a regulatory decision about a product, not a recommendation, and it does not measure how well the product works in your own setting. Confirm the current status and the exact cleared indication on the FDA record before you buy.