Insightec Gets FDA’s Premarket Approval for Exablate Neuro for Parkinson's Disease

Insightec has received the FDA’s premarket approval for its Exablate Neuro, intended to treat advanced Parkinson's Disease patients suffering from mobility, rigidity or dyskinesia symptoms.

"Movement disorder neurologists now can offer their Parkinson's patients a less invasive surgical option as part of their treatment plan," Paul Fishman, professor of neurology, pharmacology and neurobiology at the University of Maryland School of Medicine, said, according to a company statement.

The Exablate Neuro uses focused ultrasound waves to precisely target and ablate the globus pallidus during a pallidotomy, according to Miami, Fla.-based Insightec. The treatment is incisionless, does not require brain implants and has less risk of infection than invasive surgery, the company says.