FDA clears EEG technology Epilog PreOp

 

Epilog ready to enter US market

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New York, January 10th, 2018 – Epilog is excited to launch Epilog PreOp in the US market after receiving FDA clearance. Epilog PreOp is the trustworthy assistant for long-term EEG diagnostics and source localization during preoperative evaluation in epilepsy.

Around 3.4 million people in the USA live with epilepsy, with 30% of them suffering from medically refractory epilepsy.For these patients, epilepsy surgery can be a curative treatment. To obtain successful outcome after surgery, it is necessary to accurately delineate the epileptogenic zone, i.e. the brain region that causes the seizure. This is done based on several technical investigations, such as brain MRI and non-invasive scalp electro-encephalography (EEG). EEG is usually interpreted visually by the epileptologist, but this is very labor intensive and does not yield localization information within the brain.

Using state-of-the art electrical source imaging techniques, Epilog PreOp provides epileptologists with such localization. By combining patient-specific MRI images with the recorded EEG, PreOp achieves unsurpassed localization accuracy. As the Epilog web-based service model only requires a simple up- and download of data, Epilog PreOp additionally reduces time investment and increases patient throughput.

The accuracy of the methods used by Epilog PreOp was shown to result in a high sensitivity and specificity to localize the epileptogenic zone (van Mierlo et al., 2017, Epilpsia Open). Through its ease-of-use, Epilog PreOp removes the technical and practical barrier that still exists to use advanced diagnostic EEG technology in clinical routine.

With the FDA clearance, we are now able to also focus on the US market and offer a solution to epilepsy centers to help treat patients with refractory epilepsy even better.

“We are delighted that we can now also support US epileptologists. The FDA clearance coming just 9 months after launching in Europe is the evidence of our long-term commitment to bring our technology to epilepsy patients around the world” (Gregor Strobbe, CEO Epilog)
 
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About Epilog: Epilog is a spin-off company from Ghent University (Ghent, Belgium) and was founded in 2016. Epilog has offices in Ghent and New York City and provides EEG diagnostic technology tailored to clinical professionals through a customer oriented service model.

1 Morbidity and Mortality Weekly Report from the Centers for Disease Control and Prevention (CDC). National and State Estimates of the Numbers of Adults and Children with Active Epilepsy — United States, 2015. Weekly / August 11, 2017 / 66(31);821–825.