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March 28, 2022

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

The device stimulates the peroneal nerve and activates the calf and foot muscle pumps.

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.

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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.

Non-invasive, wearable and easy to use, the geko device is the size of a wristwatch and can be worn at the knee.

It gently stimulates the common peroneal nerve and activates the calf and foot muscle pumps, which increases blood flow in the deep veins of the calf.

The company stated that the disposable device operates without the need for any external leg pressure and allows complete mobility.

It noted that the new (W3) geko device variant includes a third electrode, which enables significant nerve stimulation, as well as improved patient outcomes and comfort.

Additionally, the new device variant increases to two 12-hour therapeutic doses, from the two six-hour doses that the (W2) device provided.

Sky Medical Technology CEO and founder Bernard Ross said: “Achieving this latest 510(k) clearance for the geko device (W3) establishes Sky’s position as a leading innovator in MedTech dedicated to improving patient outcomes.

“Conditions such as venous insufficiency and ischemia are therapy areas sorely in need of innovation, and we are pleased to contribute to improvements in this care pathway that make recovery quicker, simpler and more comfortable.”

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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