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# Expanded Parkinson’s Use OK’d for Insightec Device
- URL: https://www.fdaweb.com/expanded-parkinsons-use-okd-for-insightec-device/
- Published: 2025-07-08T12:00:00.000Z
- Updated: 2026-09-14T15:15:54.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159468

FDA has approved an expanded indication for Insightec’s Exablate Neuro platform for staged bilateral pallidothalamic tractotomy treatment in patients living with advanced Parkinson's disease (PD). The device previously received approval for unilateral treatment of medication-refractory essential tremor in 2016, tremor-dominant PD in 2018, and unilateral pallidotomy for Parkinson's-related dyskinesia and motor symptoms in 2021.

The new indication covers both the initial and the subsequent staged procedure,which the company says enables comprehensive bilateral treatment. “This provides an expanded therapeutic option for patients suffering from severe motor symptoms such as rigidity, bradykinesia, and dyskinesia due to PD who haven't found relief from medication,” it explains.

Insightec says Exablate Neuro uses focused ultrasound to “precisely treat targeted areas in the pallidothalamic tract, guided by MRI. The procedure is incisionless, does not require implanted hardware, and offers a lower risk profile compared to traditional surgical interventions.”

Approval is based on data from a clinical trial conducted at nine centers across the U.S., Europe and Asia, which demonstrated “encouraging outcomes that played a key role in supporting FDA approval,” according to the company. Full results from the study are expected to be published later this year.