KarmelSonix Chairman Peter Marks stated “The FDA clearance marks the full transition of KarmelSonix Ltd from a technology company to the next phase of commercial activities. The Company can now confidently mobilize products to clinical sites for regular clinical use and market acceptance through the comprehensive clinical engagement plan that has been developed in the USA and around the world."
KarmelSonix will now immediately submit the WIM-PC™ for European approval (CE mark) followed by the Australian market (TGA) approval”.
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