UNEEG Medical has received FDA 510(k) clearance for its UNEEG EpiSight System, a minimally invasive implant designed for continuous, long-term EEG monitoring in patients with epilepsy.
The system uses a small subcutaneous implant placed beneath the skin to record brain activity over extended periods in real-world settings. Combined with analytics, it aims to help clinicians better track seizures, identify patterns, and improve treatment decisions.
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UNEEG CEO Martin Stenfeldt said:
“We believe that better data leads to better decisions. By moving beyond isolated clinical snapshots, our solution enables deeper insights into patients’ everyday lives and supports more personalized and effective treatment.”
The company highlighted that EpiSight is designed to allow patients to undergo MRI scans under specific conditions (1.5T or 3T) without removing the device.
The FDA clearance marks a major step toward U.S. commercialization and expands UNEEG’s efforts to improve epilepsy care through continuous brain monitoring technology.
