The FDA accepts Edap's (EDAP +9.5%) pre-market approval application for its ultrasound device...


The FDA accepts Edap's (EDAP +9.5%) pre-market approval application for its ultrasound device for treating low-risk, localized prostate cancer. The next step for the product, which is called the Ablatherm Integrated Imaging HIFU (High Intensity Focused Ultrasound), is the filing review. Both assessments look at the completeness of the application and not the clinical outcomes of the study. (PR)

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