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# InSightecs Exablate Regulatory Review Period Determined
- URL: https://www.fdaweb.com/insightecs-exablate-regulatory-review-period-determined/
- Published: 2018-12-05T12:00:00.000Z
- Updated: 2026-09-15T00:48:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142966

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for InSightec’s medical device Exablate, indicated for use in the unilateral thalamotomy treatment of idiopathic essential tremor patients with medication-refractory tremor. The regulatory review period has been determined to be 2,050 days, which included 1,785 days that occurred during the testing phase and 265 days during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-12-04/pdf/2018-26282.pdf?ref=fdaweb.com).