Focus begins phase III trial

AuntMinnie.com staff writers

Aug 8, 2006

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

Related Reading

Misonix begins Hungarian sales, August 4, 2006

Misonix enters French market, July 25, 2006

Misonix takes controlling stake in U.K. distributor, April 11, 2006

Sonoblate 500 available in South Africa, December 2, 2005

Misonix promotes Constantine, November 23, 2005

Copyright © 2006 AuntMinnie.com

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