France based EDAP has announced 510k approval for it’s new lithotripsy device.
Marc Oczachowski, EDAP’s Chief Executive Officer, said, “We are very pleased that the U.S. 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 U.S. approval, we will be positioned to enter one of the largest global markets for lithotripsy. This is an excellent opportunity for EDAP. We will now actively market Sonolith I-Sys and its patented electroconductive technology. We strongly believe that this is the most advanced and robotized lithotripsy system and that it will play a role in the high end market in the U.S. as it was designed to respond to the specificities of this established market.”
EDAP, publically traded in the US saw it’s shares jump significantly from 1.37 USD to over 4 USD.
