EDAP TMS SA (EDAP), a minimally-invasive therapeutic solutions company for urology, has received US FDA 510(K) approval for its newly designed, high-end Sonolith I-Sys device intended to break up the urinary stones.
Sonolith I-Sys is a novel, robotized device which has been developed by EDAP to provide a highly effective product configuration to address lithotripsy markets in the world. The integrated lithotripter utilizes EDAP’s unique and patented electroconductive technology, an advanced shockwave approach differentiated by its superior ability to successfully disintegrate urinary stones in association with combined x-ray or ultrasound systems.
In July 2007 the Sonolith I-Sys received CE mark approval and was launched in the EU in late 2007. The device’s x-ray and ultrasound imaging systems and user friendly features have contributed to positive treatment outcomes, impressive adoption and high standards which benefit both patients and hospitals.
Marc Oczachowski, EDAP’s Chief Executive Officer, said: We are very pleased that the US FDA has granted 510(k) approval for Sonolith I-Sys, which marks a clear milestone for EDAP, further validates our technology and supports our objective to expand the Sonolith I-Sys into additional geographic territories. With the US approval, we will be positioned to enter one of the largest global markets for lithotripsy. This is an excellent opportunity for EDAP. We will actively market Sonolith I-Sys and its patented electroconductive technology.”