FDA approves pivotal US study of PRECISIS' under-the-scalp epilepsy stimulator
The EASEE system stimulates the brain from beneath the scalp, without touching the brain, for people with drug-resistant focal epilepsy.
German company PRECISIS has received FDA authorization to run a pivotal US study of EASEE, a minimally invasive brain stimulation system for people with drug-resistant focal epilepsy. EASEE’s electrodes are placed under the scalp, on top of the skull, so the device stimulates the seizure focus without touching or penetrating the brain. It is already CE-marked in Europe.
A pivotal study is the final major step before seeking FDA approval. EASEE could offer a less invasive option than implanted brain stimulators for people whose seizures don’t respond to medication.
Learn more: Closed-loop systems · Clinical trial pathway · PRECISIS