Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Sub-Scalp Implanted Electroencephalogram System For Remote Patient Monitoring

FDA product code SEM · 1 cleared devices

Class 2 Neurology
Regulation
21 CFR 882.1360
Review panel
NE
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-06-11 – 2026-06-11

A sub-scalp implanted electroencephalogram (EEG) system for remote patient monitoring is a prescription device used for continuously acquiring, transmitting, and storing electrical brain activity of patients with epilepsy. The device consists of sub-scalp implanted electrodes that are connected to a transmitter or storage device. The device is used to aid clinicians in the remote monitoring of electrical activity in the patient’s brain. The device is not intended to be implanted in brain tissue.

↑