Medical devices company, Sky Medical Technology has gained FDA 510(k) clearance for its geko medical device for treating pre and post-operative oedema in the US.
The company’s neuromuscular electrostimulation technology will now be used to improve patient care in the lead up to and after orthopaedic surgery.
In the past 12 months, Sky Medical has entered numerous new markets through sales or distributor partnerships and now has a direct presence in 34 countries.
Commenting on the breakthrough, Sky Medical Technology CEO, Bernard Ross, said: “The American healthcare market is receptive to any new innovation that can provide high-impact therapies that address unmet clinical needs, and this latest clearance reflects our strengths in this very arena. Our cutting-edge products and evidence-based therapies - developed in the UK and then exported globally - are helping to establish new standards of care that simplify treatments for clinicians and improve patient outcomes.”
“To provide some context on the market potential”, Ross continued, “there are around 700,000 knee replacements and 300,000 hip replacements performed in the US every year, all of which could benefit from the use of geko™. This is not to mention fractures and other orthopaedic surgery where oedema reduction is paramount.”
“We’re exploring a growing number of research streams for the use of our core technology and anticipate further international growth in the coming year”, said Ross.
“Central to our success overseas has been our proven model of partnering with many inspiring healthcare practitioners that actively seek out ways to transform how healthcare is delivered. The growth of our export business has been a direct result of our collaboration with early adopters in the UK to generate proven clinical and health economic data that can translate globally”.