Insightec Submits PMA for Exablate Neuro Treatment

Insightec has submitted a premarket approval application to the FDA for its Exablate Neuro treatment of essential tremor.

Utilizing high intensity focused ultrasound to thermally ablate the target tissue and continuous MRI, the treatment helps to visualize the anatomy, plan treatment and monitor treatment outcomes.

MR guided focused ultrasound therapy is used to relieve tremor in the brain, performing a non-invasive thalamotomy through intact skull.

Essential tremor affects more than 5 million people in U.S. and millions more around the world, the Tirat Carmel, Israel-based company says. — Michael Cipriano