Med-Tech Innovation July 28, 2020
Neil Buckley, head of quality and regulatory affairs at Sky Medical Technology, outlines the process of applying for FDA clearance and suggestions for best practice.
Sky Medical Technology has gained nine FDA clearances for its geko device. The small wrist-watch sized device sends a painless electrical pulse to the common peroneal nerve to activate the calf and foot muscle pumps. This results in increased blood flow in the deep veins of the calf to address life threatening blood clots and complications related to swelling after orthopaedic surgery – conditions experienced by more than 1 million US patients with unmet need every year.
What is the FDA and why does it matter?
The US Food and...
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