EDAP Gains U.S. FDA 510(k) Lithotripter Clearance

EDAP TMS SA EDAP announced it has received marketing clearance from the U.S. Food and Drug Administration (FDA) for its Sonolith i-move device, a technologically advanced compact mobile lithotripter. The U.S. FDA has cleared EDAP's Sonolith i-move device for fragmentation of kidney stones, extracorporeal shock wave lithotripsy procedures and endourology applications. Marc Oczachowski, EDAP's Chief Executive Officer, commented, "This FDA clearance is a major milestone for EDAP and its U.S. business. The Sonolith i-move lithotripter is a technologically advanced device with modularity and mobile capability. We believe our Sonolith i-move is attractively positioned to take market share in the U.S., the second largest lithotripsy market worldwide. Our established U.S. sales and marketing organization has clearly identified potential customers within this dynamic lithotripsy market." Marc Oczachowski added, "Our Sonolith platform offers both patients and physicians innovative efficient technology to treat urinary stones. The state-of-the-art technology and high level of innovation brought by both the Sonolith i-move and i-sys devices will enable us to renew our existing installed base of lithotripters and to maximize opportunity to take market share from the competition in the U.S."