FDA-cleared AI devices for neurology 2019
2019 has 5 neurology AI devices, 16.7% fewer than 2018 (6). That is 6.8% of the 73 neurology devices on the FDA list, and 6.3% of all AI-device decisions dated 2019. The companies are 7D Surgical Inc. (1), BrainScope Company, Inc. (1), Coapt, LLC (1), Oculogica, Inc. (1), Otto Bock Healthcare Products GmbH (1). The newest is 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application from 7D Surgical Inc., decided on November 27, 2019.
Companies in 2019
By month
Product codes
All 5 devices
- 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application7D Surgical Inc. · Neurology
- BrainScope TBIBrainScope Company, Inc. · Neurology
- Myo PlusOtto Bock Healthcare Products GmbH · Neurology
- EyeBOXOculogica, Inc. · Neurology
- COMPLETE CONTROL System Gen2Coapt, LLC · Neurology
Frequently asked questions
How many FDA-cleared AI neurology devices were there in 2019?
5 AI-enabled neurology devices have a final decision dated 2019, from 5 companies.
How does 2019 compare with 2018 for AI neurology devices?
2019 has 5 neurology AI devices, 16.7% fewer than 2018 (6).
Which companies cleared the most AI neurology devices in 2019?
7D Surgical Inc. (1), BrainScope Company, Inc. (1), Coapt, LLC (1).
What was the most recent AI neurology device in 2019?
7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application from 7D Surgical Inc. (K192945), decided on November 27, 2019. Product code HAW.
Which product codes were most common for AI neurology devices in 2019?
GXY (Electrode, Cutaneous): 2; HAW (Neurological Stereotaxic Instrument): 1; PIW (Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid): 1.
Cite as: AI Device Radar, “FDA-cleared AI devices for neurology 2019,” https://ai-device-radar.vercel.app/specialty/neurology/2019 (FDA list through 2026-06-29).