Specialty

FDA-cleared AI neurology devices

The FDA's AI-enabled device list has 73 devices whose lead review panel is Neurology, 4.5% of all 1,614 listed devices. They come from 55 companies. The first decision was on November 17, 2014 and the most recent on June 27, 2026.

73AI devices
45Companies
2014First decision
2026-06-27Latest decision

Guides for neurology

Top neurology AI devices202682025192024152023112019520186

Trend: devices per year

2014: 12015: 12016: 12018: 62019: 52020: 12021: 32022: 22023: 112024: 152025: 192026: 8
201420152016201820192020202120222023202420252026
FDA-cleared AI neurology devices per year: 2014 1, 2015 1, 2016 1, 2018 6, 2019 5, 2020 1, 2021 3, 2022 2, 2023 11, 2024 15, 2025 19, 2026 8

Top companies

Most common product codes

OLO10 devicesOLZ9 devicesHAW8 devicesOMB8 devicesQPF6 devicesGXY5 devicesSBF5 devicesPOS4 devices

All 73 devices, newest first

Frequently asked questions

How many FDA-cleared AI neurology devices are there?

As of the FDA list updated through June 29, 2026, 73 AI-enabled devices have Neurology as their lead review panel (4.5% of the list).

Which companies have the most AI neurology devices?

Brainlab AG (6), Beacon Biosignals, Inc. (3), Oculogica, Inc. (3) have the most AI-enabled neurology devices on the FDA list.

Which year had the most AI neurology authorizations?

2025 had the most, with 19 devices.

Which FDA pathways are used for AI neurology devices?

510(k): 69; De Novo: 4.

What was the most recent AI neurology device on the list?

SOMNUM (SOMNUM) from Honeynaps Co., Ltd. (K253390), with a decision dated June 27, 2026.