The new release of Persyst ESI Powered by Epilog is successfully approved for CE marking for Class IIa devices under the EU Medical Device Regulation. And it doesn't stop there, the approval extends to our QMS system making it simpler and faster for us to bring other Class IIa devices to market.
This means we can continue to empower doctors to adopt EEG Source Imaging (ESI) as the standard of care for patients with refractory epilepsy by providing our unique ESI-as-a-service solution, saving valuable time and hospital resources.
And in clinical trials, it will be our in-house Digital Health Technology (DHT), ready to be used to further CNS clinical development together with other best-matched DHTs within the appropriate context of use.
