| Published July 23, 2025

Elekta receives FDA approval for Gamma Knife for epilepsy

Elekta has received 510(k) clearance from the US Food and Drug Administration (FDA) to include refractory, intractable mesial temporal lobe epilepsy (MTLE) in adults as an approved indication for Leksell Gamma Knife-radiosurgery system. The Gamma Knife directs 192 beams of gamma radiation with high precision to the area of the brain that is causing the seizures. The system has been used globally since 1968 and has treated nearly two million patients.