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FDA panel rejects Sonablate 450 HIFU device for prostate cancer

This article was originally published in Clinica

Executive Summary

A US FDA advisory panel has almost unanimously rejected SonaCare Medical’s Sonablate 450 high-intensity focused ultrasound (HIFU) device, which is designed to treat recurrent prostate cancer after radiotherapy. The panelists voted that the data with the device was not good enough to support a positive risk-benefit profile, but they suggested the company could improve their trial design and provide more data in the future.






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