August 26, 2009 - The U.S. Food and Drug Administration recently granted 510(k) marketing clearance for the newly designed Sonolith I-Sys device by EDAP TMS SA.
December 18, 2008 - EDAP TMS SA, a therapeutic ultrasound manufacturer, has filed a 510(k) marketing application with the FDA for its newly designed, high-end Sonolith I-Sys device.