We are delighted to receive this 510(k) clearance for edema reduction. The clearance reflects our strengths in providing high-impact therapies that address clinical unmet needs, Sky CEO Bernard Ross
High Wycombe, United Kingdom (PRWEB) March 07, 2018
Sky Medical Technology Ltd, parent company of Firstkind Ltd, a UK based innovator and manufacturer of medical devices, announced today it has received U.S. Food and Drug Administration (FDA) clearance to market the geko™ device for edema reduction to address all pre and post-operative clinical applications in the USA.
“We are delighted to receive this 510(k) clearance for edema reduction, said Sky CEO Bernard Ross. The clearance reflects our strengths in providing high-impact therapies that address clinical unmet needs. Expansion into edema reduction in the USA, to treat all pre and post-operative clinical applications, is a major strategic development for the company and builds on our prior 510(k) clearance for increasing blood flow and post-surgical VTE prevention; and our ambition to provide proven enhanced recovery across the USA and internationally. Through our central strategy in partnering with healthcare professionals to solve challenging medical problems, we identify and translate clinical needs into cutting-edge products and evidence-based therapies to establish new standards of care that simplify treatments for clinicians and improve patient outcomes”.
The geko™ is a battery powered, disposable neuromuscular electrostimulation device. The size of a wrist-watch and worn at the knee, the geko™ device gently stimulates the common peroneal nerve activating the calf and foot muscle pumps resulting in increased blood flow and the reduction of pre and post-operative edema. The increase in blood flow is equal to 60% of walking without a patient having to move or exert energy.
See the geko™ device at the AAOS (American Academy of Orthopaedic Surgeons) Annual meeting in New Orleans, 7-9th March, booth #6934, in the first time exhibitors area.
About Sky Medical Technology
Sky Medical Technology is a UK based medical devices company that has developed a ground-breaking neuromuscular electrostimulation platform, OnPulse™. The company develops a range of products tailored to different medical applications, selling both direct, through partnerships or distributors in each clinical area. Clinical areas of interest include VTE prevention, reduction of swelling, wound healing and elite-sport recovery. The goal in each clinical area is to improve clinical outcomes and patient care, whilst saving health system resources.