UNEEG receives FDA Breakthrough Device Designation

The designation is a result of UNEEG’s strong focus on developing novel disease management support tools with transformational and first-to-market potential.

COPENHAGEN, November 22, 2024

• To qualify for a Breakthrough Device Designation from the US Food and Drug Administration (FDA), a device technology must address an unmet need and provide evidence that it has the potential to provide for more effective treatment of patients – or as stated, "substantial clinical improvement".
• FDA Breakthrough Device Designation is granted to UNEEG’s Subcutaneous EEG Implant System and will expedite the review of this innovative technology that can potentially improve the lives of people with severe and even life-threatening epilepsy where medical treatment has not yet led to optimal outcomes.
• As part of the Centers for Medicare & Medicaid Services stated commitments to ensuring beneficiary access to medical advancements with the potential to improve health outcomes and equity, upon FDA Clearance, the Breakthrough Designation may enable important temporary coverage and payment for qualifying novel medical technologies immediately following launch.
• In addition to the US Breakthrough Designation, UNEEG’ implantable device and second-generation wireless Bluetooth-assisted and Red Dot Award-winning device has just been granted the European CE mark, after satisfying the European authorities’ stringent Medical Device Regulation (MDR), now ready for launch.

‘This designation will expedite our cooperation with the FDA and potentially allow for faster FDA Marketing Authorization,’ says Torben Sandgren, CEO of UNEEG medical. ‘Breakthrough Designation also opens up the possibility of immediately engaging with regulators and payers – making it possible for Americans with epilepsy to gain faster access to this groundbreaking technology.’

The Subcutaneous EEG Implant System supports physicians’ epilepsy management by providing 24/7 brain waves recordings (EEG) via a small subcutaneous device behind the ear. The solution can continuously record brain activity for months and year at a time.

The recorded EEG data is sent via a dedicated cloud solution to hospitals where proprietary AI-developed software automatically identifies potential seizure activity. Such data gives physicians the ultra long-term, objective and actionable insights needed to optimise disease management – all while people with epilepsy continue to live their normal, everyday lives with full mobility.