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HIFU Face-Off: US Competition Begins For Prostate High-Intensity Focused Ultrasound

This article was originally published in The Gray Sheet

Executive Summary

With the 510(k) clearance of EDAP TMS' Ablatherm HIFU and the first US procedure performed with SonaCare Medical's recently cleared Sonablate system, a European rivalry in high-intensity focused ultrasound machines for prostate cancer has moved to the US. And EDAP's CEO argues it was positive for long-term adoption that his firm's system ultimately gained 510(k) clearance as a surgical tool rather than the originally sought PMA approval for a prostate cancer indication.

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