The Insightec system uses focused sound waves to destroy targeted tissue in the prostate under MRI guidance to visualize patient anatomy for targeting and real-time temperature monitoring.

A team led by Dr. Behfar Ehdaie from the Memorial Sloan Kettering Cancer Center in New York treated 101 patients with the system, using MRI-guided focused ultrasound. At 24 months, 78 of 89 men had no evidence of grade group 2 or higher prostate cancer in the treated area. No grade 4 or grade 5 treatment-related adverse events were reported, and only one grade 3 adverse event was reported. The researchers also found there were no treatment-related deaths.

The Insightec Exablate Prostate system received 510(k) clearance in November 2021 from the U.S. Food and Drug Administration.