Miami-based healthcare company receives new FDA approval of Parkinson’s treatment

The U.S. Food and Drug Administration approved Insightec’s Exablate Neuro platform for a new Parkinson’s treatment: staged bilateral pallidothalamic tractotomy. This technique uses focused ultrasound guided by MRI to precisely target and treat brain areas involved in motor symptoms. Key features: No incisions or implants required Treats both sides of the brain in separate stages Aimed at people with advanced Parkinson’s who have severe motor symptoms (such as rigidity, slowness, and involuntary movements) and limited benefit from medications What This Means for People with Parkinson’s The new approval provides an additional option for managing difficult symptoms, offering hope to those who haven’t found relief through medication alone. It may be especially useful for individuals seeking less invasive alternatives to deep brain stimulation or other surgical interventions. Looking to the Future Insightec plans to begin offering this procedure at select medical centers in 2025, while also working to improve insurance reimbursement and expand access. More than 25,000 people worldwide have already been treated with Insightec’s technology for movement disorders, and the platform is being explored for other conditions, including Alzheimer’s disease. A Leader in MedTech Innovation Founded in Israel in 1999 and now based in Miami, Insightec has secured more than $800 million in funding. CEO Maurice R. Ferré, a long-time leader in medical technology, called the approval a major milestone in expanding safe, effective, and non-invasive care for people living with Parkinson’s.