FDA Clears Profound’s Prostate Tissue Ablator

Profound Medical has earned 510(k) clearance for its Tulsa-Pro device, a prostate tissue ablation system.

The system uses real-time magnetic resonance imaging alongside robotically-driven transurethral ultrasound to ablate whole-gland or partial prostate tissue without incisions or radiation. It also uses water cooling to protect the urethra and rectum.

Using the device, surgeons are able to perform prostate tissue ablation procedures on both malignant and benign tissue types.