High Intensity Focused Ultrasound

Focal One®

Focal One® brings the answer to all requirements for ideal focal HIFU ablation: accurate and MR-fused imaging, non-invasive surgical approach, as well as precise and efficient therapeutic energy.



Stereotactic Lithotripsy. "Freeline" ultrasound localization system. A user-friendly system to guarantee the best treatment efficacy. Available on the Sonolith® product range.

Jan 14, 2021
Positive 24 month interim results of French Urology Association (AFU) sponsored clinical trial study comparing HIFU to radical prostate surgery: results on 3,329 patients demonstrate significant difference in efficacy in favor of HIFU versus Radical Prostatectomy (RP). Read more
Dec 9, 2020
U.S. Centers for Medicare and Medicaid Services (CMS) has issued its final rules establishing, for the first time, a Category 1 CPT code which facilitates reimbursement for the ablation of malignant prostate tissue with HIFU technology, effective January 1, 2021. Read more
Sep 3, 2020
the first two patients have been treated in the company’s Phase 2 clinical trial assessing Focal One® High Intensity Focused Ultrasound (HIFU) as a potential treatment for deep rectal endometriosis. A total of 38 women will be enrolled in the study and treated at five major hospitals and assessed over a six-month follow-up period. Read more
Aug 25, 2020
EDAP TMS has received approval from French health authorities to initiate a Phase II multicenter clinical trial evaluating its Focal One® HIFU to treat deep rectal endometriosis. Read more
Aug 18, 2020
Studies conducted at the University of Southern California and University of Miami represent the first U.S. publications detailing successful partial-gland ablation using high intensity focused ultrasound therapy to treat prostate cancer patients since FDA cleared the technology in 2015. Read more

ESWL and stone laser

Stone Management

As a world leader in extracorporeal lithotripsy for more than 30 years, EDAP TMS offers a complete range of non-invasive and minimally invasive solutions covering the full scope of Urinary Tract Stone Indications.

High intensity focused ultrasound

HIFU for Prostate Tissue Ablation

As an alternative to standard radical therapies to treat prostate conditions, EDAP TMS offers a non-invasive solution to ablate prostate tissue based on High Intensity Ultrasound (HIFU)…