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

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.

SonaCare Medical LLC will go before FDA’s Gastroenterology and Urology Devices Panel with its Sonablate 450 high intensity focused ultrasound device for prostate cancer on Oct. 1.

The Charlotte, North Carolina, firm is seeking PMA approval to sell the device to treat localized prostate cancer that has...

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