Sonolith i-move lithotripter from EDAP TMS receives FDA 510(k) approval
Sonolith® i-move, the high-tech latest generation of Sonolith lithotripters just received FDA approval.
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."