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FDA grants 510(k) clearance for Sky Medical’s new geko device variant

March 28, 2022

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The US Food and Drug Administration (FDA) has granted 510(k) clearance for the marketing of Sky Medical Technology’s new (W3) geko device variant.

The new device has been designed to increase microcirculatory blood flow in lower limb soft tissue in venous insufficiency and/or ischemia patients.

Last year, the company also received FDA approval for its (W2) geko device for venous insufficiency and/or ischemia, which is related to the reduced flow of blood in the veins and arteries.

Read More on medicaldevice-network.com