EDAP TMS S.A.

Nov 20, 2025 - EDAP TMS SA  has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance ...

Jan. 8, 2025 - EDAP TMS SA, a supplier of robotic energy-based therapies, has announced that the first patient has been ...

EDAP TMS SA announced that Houston Methodist Hospital, one of the first hospitals in the U.S. to offer Ablatherm robotic high intensity focused ultrasound (HIFU) for patients with localized prostate cancer, has acquired the advanced Focal One HIFU technology. Houston Methodist Hospital initially invested in EDAP's first-generation HIFU system, Ablatherm, in early 2016, and within two years of positive experience made the decision to invest in the next-generation Focal One device.

EDAP TMS SA announced the publication of a peer-reviewed article that analyzed Ablatherm Robotic HIFU (high-intensity focused ultrasound) for prostate tissue ablation in patients who had previously undergone radiotherapy treatment. The article concludes that HIFU should be considered as a valuable therapeutic option for carefully selected patients who failed a previous radiotherapy treatment. The article was published in the January 2017 edition of the British Journal of Urology International.

March 12, 2013 — EDAP TMS SA announced that the U.S. Food and Drug Administration (FDA) has provided a positive administrative acceptance review notification for the company's premarket approval (PMA) application for its Ablatherm integrated imaging HIFU (high-intensity focused ultrasound) device for treatment of low-risk, localized prostate cancer.