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Focus Surgery Seeks IDE For Sonablate HIFU Prostate Cancer Treatment

This article was originally published in The Gray Sheet

Executive Summary

Focus Surgery says it will file an investigational device exemption application with FDA in mid-to-late 1999 to begin U.S. clinical trials of the Sonablate 200 high-intensity focused ultrasound (HIFU) system for treatment of prostate cancer.

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Misonix Sonablate PMA Submission For BPH Expected In September

Misonix is looking toward a late September premarket approval application filing date for the Sonablate 200 high intensity focused ultrasound (HIFU) device in treating benign prostatic hyperplasia. Commercial release of the product in the U.S. is expected sometime in 2001.

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