by
Gus Iversen, Editor in Chief | July 10, 2025
The U.S. FDA has approved Insightec’s Exablate Neuro platform for staged bilateral pallidothalamic tractotomy in patients with advanced Parkinson’s disease, expanding the device’s use beyond previously cleared unilateral procedures.
The Haifa, Israel- and Miami-based company said the clearance allows for a two-stage process that treats both sides of the brain, offering an additional option for patients who experience severe motor symptoms such as rigidity, bradykinesia, or dyskinesia despite medication.
The procedure, which does not require incisions or implanted hardware, uses focused ultrasound guided by MR to ablate targeted brain tissue. Insightec says this approach may present a lower risk profile than traditional surgical options.
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“This new indication represents a significant step forward in how integrated movement disorder teams will approach the treatment of Parkinson's disease,” said Dr. Michael Kaplitt, a neurosurgeon at Weill Cornell Medicine–New York Presbyterian Hospital, and lead investigator of the supporting clinical trial.
The multinational study was conducted at nine centers across the U.S., Europe, and Asia. Results have not yet been published but were central to the FDA's approval.
Insightec said it will initiate a limited rollout of the bilateral procedure at select centers in 2025, while also working to establish reimbursement pathways.
Parkinson’s disease affects nearly one million Americans today, a number expected to surpass 1.2 million by 2030. While medications remain the first-line treatment, many patients eventually seek alternatives due to side effects or waning effectiveness.
The Exablate Neuro platform has received prior FDA approvals for treating essential tremor and Parkinson’s-related tremor and dyskinesia, with over 25,000 patients treated globally to date.
Both Dr. Kaplitt and Dr. Arif Dalvi, director of the Comprehensive Movement Disorders Center at Palm Beach Health Network and a top-enrolling investigator in the trial, disclosed financial relationships with Insightec.
