Insightec’s Exablate Prostate Tissue Treatment Device Cleared

Insightec has received the FDA’s 510(k) clearance for its Exablate Prostate system, which is designed for removal of prostate tissue using sound waves.

The ultrasound treatment is guided by magnetic resonance imaging (MRI) for high-resolution visualization of the patient's anatomy to ensure precise targeting.

The treatment does not require incisions and is performed in a single session, allowing patients to quickly return to normal activity with minimal complications, the Haifa, Israel-based company said.