Sky receives FDA clearance to market the geko™ device for venous insufficiency and ischemia
On December 16, 2021, Sky Medical Technology Ltd, a medical device company, got approval from the US Food and Drug Administration (FDA) 510(k) to market the geko™ device for growing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia.
Bernard Ross, CEO and Founder, said that achieving this latest 510(k) clearance is a major milestone for Sky, which will enable them to start a controlled market release of the geko™ device to address venous insufficiency and ischemia in the first instance, a ...
