The FDA has granted EDAP TMS out of Lyon, France marketing approval for the Sonolith I-Sys integrated lithotripter. The system features company’s proprietary Electroconductive Technology, a touchscreen monitor for identifying stones (via X-rays or ultrasound) and, once targeted, the table automatically (robotically) adjusts to get the energy beam to precisely hit the stone.
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.
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.
Press release: EDAP Receives U.S. FDA 510(k) Approval for Sonolith I-Sys …
Product page: Sonolith® i-sys integrated lithotripter …