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Dec. 4, 2024 - EDAP TMS SA, a leader in robotic energy-based therapies, recently announced the publication of the full ...
December 18, 2024 
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.
March 19, 2019 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.
June 19, 2018 
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 29, 2017 
EDAP TMS SA received a letter from the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) on its current premarket approval (PMA) application for the Ablatherm integrated imaging device for high-intensity focused ultrasound (HIFU).
January 08, 2015 
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.
March 12, 2013 
EDAP TMS SA announced the submission of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) on Jan. 31, 2013 for the Company's Ablatherm-HIFU (high intensity focused ultrasound) for treatment of low risk, localized prostate cancer. EDAP's PMA submission includes data from the ENLIGHT study, a multi-center U.S. Phase II/III clinical trial that completed the two year follow-up needed to evaluate its primary endpoint in August 2012, as well as data from the company's extensive worldwide database of treatment information and follow-up data from patients who have undergone HIFU therapy for prostate cancer.
February 08, 2013 
August 26, 2009 - The U.S. Food and Drug Administration recently granted 510(k) marketing clearance for the newly designed Sonolith I-Sys device by EDAP TMS SA.
August 26, 2009 
December 18, 2008 - EDAP TMS SA, a therapeutic ultrasound manufacturer, has filed a 510(k) marketing application with the FDA for its newly designed, high-end Sonolith I-Sys device.
December 18, 2008 September 10, 2008 - EDAP TMS SA, a therapeutic ultrasound developer, will launch initial HIFU services, a noninvasive ...
September 09, 2008