FDA Greenlights Pivotal Study of PRECISIS’ Minimally Invasive Brain-Stimulation Therapy for Drug-Resistant Epilepsy
Heidelberg, Germany – November 6, 2025. PRECISIS GmbH today announced that the U.S. Food & Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval for its pivotal EASEE4US clinical study, marking a significant step toward U.S. market entry for its first-in-class epilepsy neuromodulation technology. Unlike traditional surgical neurostimulation implants, EASEE® electrodes are placed under the scalp and above the skull, offering a minimally invasive, targeted approach intended to fill the treatment gap between medication and brain surgery.
