
UNEEG Medical received FDA 510k clearance for its EpiSight system, advancing its implantable, long-term EEG monitoring platform in the US. The subcutaneous device captures continuous seizure data outside the clinic, addressing the gap between brief in-clinic EEG and patient-reported seizure diaries in epilepsy management. The clearance follows the company's earlier Breakthrough Device designation and CE mark and opens a US commercial pathway for ultra-long-term monitoring.