June 19, 2018 — EDAP TMS SA has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Focal One device for the ablation of prostate tissue.
The Focal One high intensity focused ultrasound (HIFU) device is the first medical apparatus designed specifically for focal treatment of the prostate, according to the company. Focal One fuses magnetic resonance (MR) and 3-D biopsy data with real-time ultrasound imaging. This allows urologists to view integrated, detailed 3-D images of the prostate on a large monitor and direct high intensity ultrasound waves to ablate the targeted area.
With Focal One, urology surgeons can establish precise contours around the diseased tissue and ablate an even smaller portion of the prostate. This lessens the damage to healthy tissue, and minimizes side effects of incontinence and impotence for patients. Using Focal One, surgeons can customize the HIFU procedure for each patient and each clinical condition.
"Focal One is a great step forward in using this new and important ultrasound technology for prostate tissue ablation," said Brian Miles, M.D., urologist, professor of urology, Houston Methodist Hospital - Weill Cornell Medical College. "Focal One's ability to merge MRI images, ultrasound images and biopsy data in order to precisely outline and treat just the diseased tissue area of the prostate is truly remarkable."
For more information: www.edap-tms.com
March 13, 2026 
