Rochester, NY 8/22/2009 7:49:53 AM
EDAP TMS S.A. (ADR) EDAP, EDAP announces to Receives U.S. FDA 510(k) endorsement for Sonolith I-Sys
EDAP TMS S.A. (ADR)
EDAP TMS SA EDAP, the global leader in therapeutic ultrasound, announced today that the U.S. Food and Drug Administration has granted 510(k) marketing clearance for its newly designed, high-end Sonolith I-Sys device.
Sonolith I-Sys is a novel, robotized device that has been developed by EDAP to provide a highly effective product configuration to address what is one of the largest lithotripsy markets in the world. The integrated lithotripter utilizes EDAP's unique and patented electro conductive technology, an advanced shockwave approach differentiated by its superior ability to successfully disintegrate 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 superior x-ray and ultrasound imaging systems and user friendly features have contributed to its impressive adoption, positive treatment outcomes and high standards that benefit both patients and hospitals.
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