High-intensity focused ultrasound (HIFU) developer Focus Surgery has received a provisional investigational device exemption (IDE) from the U.S. Food and Drug Administration, allowing the firm's Sonablate 500 system to be used in a multicenter clinical study.
The study will collect safety and efficacy data for final FDA clearance, and will use HIFU for the treatment of low-risk, localized prostate cancer (T1c/T2a), according to the Indianapolis-based firm. The study will enroll approximately 466 subjects at 24 institutions, Focus said.
By AuntMinnie.com staff writers
August 9, 2006
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