UNEEG EpiSight launch

UNEEG medical announces world's first wireless, ultra long-term EEG recording of people with severe epilepsy – breakthrough features AI-supported analytics software for seizure and sleep correlation

With CE mark approval, the benefits of the subcutaneous UNEEG EpiSight solution are now available with the unique implantable chip and advanced software.

COPENHAGEN, September 7, 2024 - UNEEG medical, a Danish company pioneering in neuro- and epilepsy science, today announced the Europe-wide launch of its RedDot award-winning wireless UNEEG EpiSight solution.

The solution combines a unique implantable subcutaneous EEG device with app- and cloud-based features and AI software to continuously record brain activity for year and months at a time, and to easily and quickly analyse the data to detect seizures, correlate sleep patterns, and help optimize treatment regimens.

UNEEG EpiSight has recently been granted CE marking, (Conformité Européenne), meaning it can be traded automatically on the extended Single Market in the European Economic Area (EEA). The CE mark signifies that the solution has been independently assessed to meet high safety, health, and environmental protection requirements.

The solution, which will be available in the entire Europe, is being presented at the International League Against Epilepsy conference in Rome, Italy, September 7 – 11.

With the UNEEG EpiSight solution, the patient is fitted with a subcutaneous EEG device that records brain activity 24/7 for up to 15 months (soon to be 3 years, upon CE-approval expected this autumn). Data is stored on a discrete wireless recorder and sent to the hospital every day. The AI software identifies potential seizure activity and sleep patterns, providing physicians with actionable insights—all while patients continue to live their normal, everyday lives.

Such objective, longitudinal data from everyday life has never been available before, and marks a paradigm shift in epilepsy management.

Commenting on the solution, UNEEG medical CEO Torben Sandgren says: ‘It gives treating physicians the ultra long-term data they need to fully understand seizure burdens. Currently physicians must rely on data gathered from at most a week or two,’ and continues ‘having access to such objective brain data, medication can be optimized thus reducing both the seizure burden as well as the harsh side-effects of the anti-seizure medication people with severe epilepsy are struggling with’.

A challenging aspect of suffering from epilepsy is keeping track of daily seizures, but accurate recording is difficult, and there is always a risk of over- or underestimating the number of seizures. For example, seizures may occur during sleep, or may not be recognized as seizures. However, because of its responsive algorithm, the UNEEG EpiSight solution can help patients, even when they are unable to report their seizures. The system gives them and their physicians an objective, reliable measure of seizure burdens 24/7.

This paradigm shift is recognized by one of Europe’s leading physicians, Prof. Mark Richardson from King’s College London: ‘UNEEG EpiSight is an opportunity for us to address the issue of inaccurate self-reporting—to give us robust outcome measuring in the form of electrographic evidence of a seizure instead of self-reporting.’

For people with epilepsy, knowing that all their seizures are being recorded can come as a significant relief. As one wearer reported: ‘It is small, it is easy, it is simple. I won’t miss a seizure should it happen. It is my diary.’

The solution has already improved the quality of life for people with epilepsy, giving them a clearer picture of their seizures and medication effect on a daily basis, as part of public and private health schemes in Germany, Austria and Switzerland (through German Krankenkasse and Swiss Health insurance system, KoGu). Patients have also benefitted from clinical studies and trials at hospitals in the United States, the United Kingdom, Ireland, Italy, Spain, Denmark, Norway and the Netherlands.

‘We're incredibly proud of the subcutaneous UNEEG EpiSight solution,’ says Sandgren. ‘We’re proud of is as a technical achievement. And especially proud that it has the potential to help so many people by becoming Europe’s most widely used system for longitudinal monitoring of severe epilepsy.’