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FDA Panel To Review SonaCare’s HIFU Device For Prostate Cancer

This article was originally published in The Gray Sheet

Executive Summary

It will be the second time this year that the Gastroenterology and Urology Devices Panel reviews a high intensity focused ultrasound system intended for prostate cancer. SonaCare is surely hoping for a better showing for its Sonablate 450 than EDAP experienced last month with its Ablatherm HIFU.

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FDA Panel Rejects Sonablate 450 HIFU Device For Prostate Cancer

The advisors voted almost unanimously that SonaCare Medical’s HIFU device did not have good enough data to support a positive risk-benefit profile, but they suggested the company could improve their trial design and try again.

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