Roundup · ranked by clearances

Best FDA-cleared AI neurology devices (2026)

The companies with the most FDA-cleared AI neurology devices through June 29, 2026 are Brainlab AG (6), BrainScope Company, Inc. (4) and Augmedics, Ltd. (3). This is a count of final decisions on the FDA list. It is not a ranking of clinical performance.

How this ranking works

Each row is one applicant name on the FDA AI-enabled device list, limited to devices whose lead review panel is Neurology. Affiliated companies are not merged. A company needs at least two neurology devices to appear in the top list. 27 other companies have exactly one. The full catalog is the neurology specialty page; 2026 alone is FDA-cleared AI devices for neurology 2026.

Top companies

  1. 1

    Brainlab AG

    Brainlab AG has 6 FDA-listed AI neurology devices (8.2% of this specialty), with decisions from 2023–2024. The latest is Automatic Registration (K234047) on March 20, 2024. Most common product code: HAW (Neurological Stereotaxic Instrument), 3 devices.

  2. 2

    BrainScope Company, Inc.

    BrainScope Company, Inc. has 4 FDA-listed AI neurology devices (5.5% of this specialty), with decisions from 2014–2019. The latest is BrainScope TBI (K190815) on September 11, 2019. Most common product code: PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid), 4 devices.

  3. 3

    Augmedics, Ltd.

    Augmedics, Ltd. has 3 FDA-listed AI neurology devices (4.1% of this specialty), with decisions from 2024–2025. The latest is xvision Spine system (K251639) on October 3, 2025. Most common product code: SBF (Orthopedic Augmented Reality), 3 devices.

  4. 4

    Beacon Biosignals, Inc.

    Beacon Biosignals, Inc. has 3 FDA-listed AI neurology devices (4.1% of this specialty), with decisions from 2023–2024. The latest is Dreem 3S (K242094) on November 22, 2024. Most common product code: OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph), 3 devices.

  5. 5

    Empatica Srl

    Empatica Srl has 3 FDA-listed AI neurology devices (4.1% of this specialty), with decisions from 2018–2025. The latest is EpiMonitor (K250515) on June 19, 2025. Most common product code: POS (Physiological Signal Based Seizure Monitoring System), 3 devices.

  6. 6

    Oculogica, Inc.

    Oculogica, Inc. has 3 FDA-listed AI neurology devices (4.1% of this specialty), with decisions from 2018–2020. The latest is EyeBOX (K201841) on September 6, 2020. Most common product code: QEA (Brain Injury Adjunctive Interpretive Oculomotor Assessment Aid), 3 devices.

  7. 7

    Ceribell, Inc.

    Ceribell, Inc. has 2 FDA-listed AI neurology devices (2.7% of this specialty), with decisions from 2023–2025. The latest is Ceribell Delirium Monitor System (K251936) on December 8, 2025. Most common product code: NCG (Neuropsychiatric Interpretative Electroencephalograph Assessment Aid), 1 device.

  8. 8

    ClearPoint Neuro, Inc.

    ClearPoint Neuro, Inc. has 2 FDA-listed AI neurology devices (2.7% of this specialty), with decisions from 2023–2025. The latest is ClearPoint System (Software Version 3.0) (K243657) on January 24, 2025. Most common product code: HAW (Neurological Stereotaxic Instrument), 2 devices.

Newest neurology clearances

The six most recent neurology decisions on the list. See every neurology device dated 2026 · All specialties in 2026

Radiology1230Cardiovascular154Anesthesiology30Gastroenterology-Urology27Hematology22

Frequently asked questions

Which company has the most FDA-cleared AI neurology devices?

Brainlab AG has the most, with 6 (8.2% of neurology devices on the list). Next are BrainScope Company, Inc. (4) and Augmedics, Ltd. (3).

How many FDA-cleared AI neurology devices are there?

The FDA AI-device list has 73 devices with Neurology as the lead review panel, from 45 companies, through June 29, 2026.

Is this a ranking of the best AI neurology devices clinically?

No. Companies are ordered by how many FDA final decisions they have on the AI-enabled device list. That measures how many authorized products an applicant has, not accuracy, safety, or which device to buy.

Which AI neurology device was cleared most recently?

SOMNUM (SOMNUM) from Honeynaps Co., Ltd. (K253390), decided on June 27, 2026.

How many AI neurology devices were cleared in 2026?

8 neurology devices have a 2026 decision date, through June 29, 2026.

Cite as: AI Device Radar, “Best FDA-cleared AI neurology devices (2026),” https://ai-device-radar.vercel.app/best/neurology (FDA list through 2026-06-29).