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# FDA Approves New Insightec Exablate Neuro Indication
- URL: https://www.fdaweb.com/fda-approves-new-insightec-exablate-neuro-indication/
- Published: 2021-11-03T12:00:00.000Z
- Updated: 2026-09-14T17:21:17.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150506

FDA has approved Insightec’s Exablate Neuro for treating advanced Parkinson’s disease patients suffering from mobility, rigidity, or dyskinesia symptoms. The company [says](https://www.marketwatch.com/press-release/insightec-announces-fda-approval-of-exablate-neuro-for-the-treatment-of-parkinsons-disease-2021-11-03?tesla=y&ref=fdaweb.com) the Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus during a pallidotomy. Insightec says the treatment is incision-less, does not require brain implants, and has less risk of infection than invasive surgery.

The device received FDA approval for treating medication-refractory essential tremor in 2016 and for tremor-dominant Parkinson’s disease in 2018, the company says.