The FDA granted 510(k) clearance to UNEEG Medical on June 15, 2026, for the UNEEG EpiSight system — a subcutaneous implant about the diameter of a large coin that records continuous EEG signals for up to three years, enabling neurologists to build a longitudinal view of brain electrical activity across months rather than days.
The Danish company received FDA Breakthrough Device Designation in November 2024, which allowed the agency to provide more intensive guidance during the review process. The 510(k) clearance itself rests on substantial equivalence to a legally marketed predicate; it is a market authorization, not a premarket approval that requires new clinical trial data demonstrating improved outcomes. Whether the extended EEG record the EpiSight produces will improve seizure outcomes or time to surgical candidacy determination will require prospective clinical evidence.
The gap the EpiSight is designed to fill is well-documented. Standard ambulatory EEG captures 24 to 72 hours of brain activity — a narrow window in a disease where most patients experience seizures days, weeks, or months apart. Repeated short-term recordings are expensive, logistically burdensome, and frequently capture no diagnostic events. Clinicians are often left adjusting antiseizure medications or making escalation decisions based on limited or incomplete electrical data.
The EpiSight implant is placed subcutaneously — beneath the skin but above the skull, without penetrating brain tissue. It transmits recordings wirelessly to an external receiver, allowing neurologists to accumulate a longitudinal EEG record between clinic visits. The device carries MRI conditional labeling at 1.5 and 3 tesla, the field strengths used by the large majority of U.S. scanners, so patients can undergo neuroimaging without removing the implant.
Epilepsy affects approximately 3.4 million Americans. About one-third of patients develop drug-resistant epilepsy — defined as failure to achieve sustained seizure freedom after at least two adequately trialed antiseizure medications. For that group, accurate long-term seizure characterization informs decisions about whether to escalate pharmacotherapy, evaluate for vagal nerve stimulation, or pursue resective surgery candidacy.
Correction, 2026-06-22: An earlier version of this article stated that “about one-third of patients do not achieve seizure control with the first antiseizure medication prescribed.” That framing misapplied a standard epidemiological benchmark: the one-third figure refers to patients who develop drug-resistant epilepsy — those who fail to respond to at least two appropriately chosen and adequately trialed antiseizure medications — not to first-drug failure specifically. First-drug failure rates are substantially higher (~50%). The sentence has been corrected.
UNEEG has not disclosed a U.S. commercial pricing or specific availability timeline. The EpiSight system has been marketed in Europe since receiving CE mark.