MYOLYN, Inc., a medical technology company, received 510(k) clearance from the Food and Drug Administration (FDA) on the medical benefits of a new, second version of their flagship product, the MyoCycle. With four new models, the MyoCycle brings revolutionary Functional Electrical Stimulation (FES) cycling therapy to both at-home and clinical-setting users. The new MyoCycle models are immediately available for sale and shipment.
GAINESVILLE, Fla., April 28, 2022 /PRNewswire-PRWeb/ -- MYOLYN, Inc., a medical technology company, received 510(k) clearance from the Food and Drug Administration (FDA) on the medical benefits of a new, second version of their flagship product, the MyoCycle. With four new models, the MyoCycle brings revolutionary Functional Electrical Stimulation (FES) cycling therapy to both at-home and clinical-setting users. The new MyoCycle models are immediately available for sale and shipment.
The new models of the FES cycling therapy system—Home, Home Plus, Pro, and Pro Plus—open an exciting, new chapter in FES therapy with advanced technologies to better meet patient needs including but not limited to: additional stimulation channel options with up to ten channels of stimulation, new walking and cycling modes, additional muscle group targeting options for core and lower leg muscles, new FDA-cleared benefit of muscle re-education, real-time performance feedback, and more adjustable stimulation parameters. The added indication for use of muscle re-education reflects the functional improvements that FES therapy can provide to patients with neurological impairments.
"The new models of the MyoCycle demonstrate MYOLYN's commitment to innovation and focus on meeting client needs. These new systems provide additional therapeutic benefits to people with more diverse needs and better meet the rigorous demands of the clinical setting while maintaining the ease-of-use that made the initial MyoCycle so successful" says MYOLYN Chief Executive Officer Alan Hamlet, PhD.
With new muscle group targeting of the core and lower legs, in addition to the thighs and glutes, the MyoCycle can benefit those who face a variety of medical conditions resulting in lower-body paralysis or muscle weakness, including spinal cord injuries, stroke, multiple sclerosis, brain injury, Parkinson's disease, cerebral palsy, foot drop, and general orthopedic rehabilitation. The new MyoCycle's ability to address this range of conditions displays a greater level of adjustability of the product to meet the range of usage demands from neurological physical therapy clinics to homes.
"The new MyoCycle models represent five years of post-market experience with the original MyoCycle models," says Chief Technology Officer Matthew Bellman, PhD. "The first MyoCycle has and will continue to help many individuals, and in listening to client feedback and looking for ways to innovate, we are excited to launch this new MyoCycle that furthers our mission to empower people to move."
MYOLYN's goal is to bring affordability and ease of access to this revolutionary therapy for all. To learn more about the benefits of the MyoCycle or to learn how to get one for yourself or a loved one, get in touch with us.
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About: MYOLYN, Incorporated is a medical technology company located in Gainesville, Florida dedicated to improving health and human performance by empowering people to move. The Company designs, manufactures, and distributes therapy systems for people with muscle weakness or paralysis. MYOLYN was co-founded in 2013 by engineers Alan Hamlet and Matthew Bellman, both of whom have received a PhD in robotics from the University of Florida.
Media Contact
Alan Hamlet, MYOLYN, Inc., 1 (352) 354-2749, [email protected]
SOURCE MYOLYN, Inc.
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