FDA Panel Votes Down Ablatherm HIFU Device For Prostate Cancer

FDA Gastroenterology and Urology Advisory panel members July 30 voted no confidence in the effectiveness and safety of EDAP TMS SA’s Ablatherm high intensity focused ultrasound thermal ablation device as a treatment for localized prostate cancer.

EDAP hopes to launch the product in the U.S. as an alternative to surgery, as it already does in Europe,...

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