FDA Grants 510(k) for Sonolith I-Sys

August 26, 2009 - The U.S. Food and Drug Administration recently granted 510(k) marketing clearance for the newly designed Sonolith I-Sys device by EDAP TMS SA.

Sonolith I-Sys is a novel, robotized device that has been developed by EDAP to provide an electroconductive technology for an integrated lithotripter. The electroconductive technology is a shockwave approach that disintegrates urinary stones in association with combined X-ray or ultrasound systems.

The Sonolith I-Sys received CE mark approval in July 2007 and was launched in the E.U. in late 2007. The device's X-ray and ultrasound imaging systems have reportedly bolstered its adoption rate.

For more information: www.edap-tms.com