Technology | December 18, 2008

EDAP Submits 510(k) Filing FDA for Sonolith I-Sys

December 18, 2008 - EDAP TMS SA, a therapeutic ultrasound manufacturer, has filed a 510(k) marketing application with the FDA for its newly designed, high-end Sonolith I-Sys device.

Sonolith I-Sys is a novel, robotized device with the potential to become the comparative assessment benchmark of next-generation lithotripsy devices. The integrated lithotripter utilizes EDAP’s patented electroconductive technology, an advanced shockwave approach that is disintegrate urinary stones in association with combined x-ray or ultrasound systems.

Sonolith I-Sys received CE mark approval in July 2007 and was officially launched by EDAP in late 2007. Currently also approved in Korea, Australia and Canada, urologists have benefited from the straightforward treatment preparation and ESWL procedure, which has a clear navigational platform software. The device has generated impressive enthusiasm among users in Europe by providing a superior x-ray imaging system and user friendly features associated with efficacious treatments and high standards that benefit both patients and hospitals.

For more information: www.edap-tms.com

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