The US Food and Drug Administration (FDA) expanded approval of Insightec’s Exablate Neuro focused ultrasound device to include patients with advanced Parkinson’s disease (PD) suffering from mobility, rigidity, or dyskinesia symptoms.
The decision was based on data from the pivotal clinical trial that took place at eight sites in the US, Canada, Japan, and Korea.
In 2016, the FDA approved focused ultrasound for the first brain indication – essential tremor. In 2018, it was approved to treat tremor-dominant PD.
There are currently 37 medical centers in the US using Insightec’s device.