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Insightec receives FDA approval for focused ultrasound treatment of Parkinson's motor symptoms

FDA Press Release4/24/2026ยท04/24/26๐ŸŒ USA

Summary

Insightec has received FDA PMA approval to expand its Exablate Neuro indication from unilateral to bilateral focused ultrasound thalamotomy for Parkinson's disease tremor, and for a new dyskinesia indication. The bilateral approval addresses the 70% of Parkinson's patients with bilateral symptoms previously excluded from FUS treatment.

Why it matters

Bilateral FUS approval dramatically expands the addressable Parkinson's population for non-surgical treatment. Insightec's revenue opportunity roughly triples with this expanded label, and the dyskinesia indication opens an entirely new market.

#BCI#FDA#Focused Ultrasound#Parkinson's

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