UNEEG Medical, a neurotech innovator, has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Subcutaneous EEG Implant System. This designation is intended to expedite the review of this innovative technology, which aims to improve the lives of individuals with severe and potentially life-threatening epilepsy who have not achieved optimal outcomes with existing medical treatments.
The Subcutaneous EEG Implant System supports physicians in managing epilepsy by providing continuous 24/7 brain wave recordings (EEG) via a small subcutaneous device placed behind the ear. This system can record brain activity for months or even years, offering a comprehensive view of a patient's neurological activity.
The recorded EEG data is transmitted through a dedicated cloud solution to hospitals, where proprietary AI-developed software analyzes the data to identify potential seizure activity. This provides physicians with long-term, objective, and actionable insights to optimize disease management, all while allowing patients to maintain their everyday lives with full mobility.
According to Torben Sandgren, CEO of UNEEG medical, this designation will expedite cooperation with the FDA and potentially lead to faster FDA Marketing Authorization. Sandgren also noted that the Breakthrough Designation opens the possibility of engaging with regulators and payers immediately, potentially allowing Americans with epilepsy to gain faster access to this technology.
To qualify for the Breakthrough Device Designation, a technology must address an unmet need and provide evidence of the potential for more effective treatment of patients, demonstrating "substantial clinical improvement." As part of the Centers for Medicare & Medicaid Services' commitments, the Breakthrough Designation may enable temporary coverage and payment for qualifying novel medical technologies immediately following launch, upon FDA clearance.
In addition to the FDA Breakthrough Designation, UNEEG's implantable device has also received the European CE mark, complying with the European authorities' stringent Medical Device Regulation (MDR), and is now ready for launch in Europe. UNEEG medical is currently conducting an FDA-approved IDE (Investigational Device Exemption) study at several leading universities in the US and Europe to further validate the technology.
