FDAnews
www.fdanews.com/articles/207180-sky-medicals-w3-geko-cleared-for-treating-venous-insufficiency-ischemia

Sky Medical’s W3 Geko Cleared for Treating Venous Insufficiency, Ischemia

March 30, 2022

UK-based Sky Medical Technology has received the FDA’s 510(k) clearance for the W3 version of its geko device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency and/or ischemia.

The company previously received an FDA clearance for the W2 version of the device for the same indications.  

The latest version, which features a third electrode, can provide two 12-hour therapeutic doses, whereas the W2 version provided two six-hour doses.

Sky has also received FDA clearance for devices for edema reduction and stimulation of the calf muscles to prevent blood clots.

View today's stories