Myolyn Gets New FDA Clearance for its MyoCycle Device

Myolyn has received the FDA’s 510(k) clearance for several new models of its flagship MyoCycle product, which provides functional electrical stimulation (FES) for patients with neurological impairments.

The new models, dubbed Home, Home Plus, Pro and Pro Plus, include up to 10 channels of stimulation, new walking and cycling modes, and the targeting of additional muscle groups for core and lower leg muscles.

Other new features include real-time performance feedback and more adjustable stimulation parameters, the company said.