MYOLYN, a medical technology company, announced that it has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for two of its cutting-edge technologies, the MyoCycle Home and the MyoCycle Pro.
Both devices are stationary cycling systems that use MYOLYN’s patent-pending functional electrical stimulation (FES) technology to empower anyone who has difficulty activating their own muscles. Such systems are also known as FES bikes.
Clearance from the FDA marks a major milestone for the technology startup, allowing MYOLYN to enter both the professional rehabilitation and the homecare medical device markets.
“FES is a very promising technology that can help many people with paralysis or muscle weakness,” says MYOLYN co-founder and CEO Alan Hamlet, PhD. “MYOLYN’s goal is to make this revolutionary technology available to the millions of people that can benefit from it. The MyoCycle is an affordable, easy-to-use FES bike that enables therapeutic, load-bearing exercise despite even complete paralysis. It is a game changer!”
An FES bike is essentially a stationary exercise bike that someone who is paralyzed can use because it activates their muscles for them. The MyoCycle is intended for general rehabilitation for relaxing muscle spasms, preventing muscle atrophy, increasing blood circulation, and maintaining or increasing range of motion following disease or injury. These indications for use make the MyoCycle especially beneficial for people with spinal cord injury, stroke, multiple sclerosis, Parkinson’s disease, and cerebral palsy, as well as people undergoing orthopedic rehabilitation following knee or hip surgery.
“Our patent-pending algorithms automatically select the optimal stimulation parameters for the patient, making the MyoCycle not only effective, but extremely easy and intuitive to use,” says Chief Technology Officer Matthew Bellman, PhD. “Our goal was to make this technology practical for use in the home for the first time, so we designed the MyoCycle from the ground up to be affordable and as easy-to-use as a regular exercise bike.”
FDA clearance enables millions of people with paralysis to engage in a complete continuum of care from the clinic, where the MyoCycle Pro helps to maximize recovery potential, to the comfort of home, where the MyoCycle Home helps people with paralysis to stay active and healthy.
- The MyoCycle Pro, intended for clinical use, combines isokinetic cycling and FES into a single system that can increase clinic revenue while maximizing patient outcomes.
- The MyoCycle Home is an affordable, easy-to-use FES bike that empowers patients to take control of their health and get the therapy they need from the comfort of home.