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FDA Questions Cross-Study Comparisons In Lead Up To EDAP’s Ablatherm HIFU Panel

This article was originally published in The Gray Sheet

Executive Summary

FDA’s Gastroenterology and Urology Devices Panel July 30 will assess EDAP TMS’ PMA in support of the Ablatherm high intensity focused ultrasound device to treat localized prostate cancer. FDA is questioning the clinical meaningfulness of comparing HIFU metastasis outcomes against data from a distinct radical prostatectomy trial.

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