MR-guided focused ultrasound (MRgFUS) developer InSightec has submitted a premarket approval (PMA) application to the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for its Exablate Neuro (Exablate 4000) device.
The system is used for treating patients with advanced Parkinson's disease who are experiencing mobility, rigidity, or dyskinesia. Exablate Neuro uses focused ultrasound together with MR imaging to treat deep within the brain with no incisions and is intended to improve motor function and reduce dyskinesia, the company said. Dyskinesia is often a side effect of medication used to treat Parkinson's disease.
