FDA Clears Mobile App for Use with L300 Go System Created to Help with Walking and Gait

The U.S. Food and Drug Administration (FDA) recently cleared the myBioness mobile app, designed by Bioness, to be used with the L300 Go System to improve muscle strength in patients with multiple sclerosis (MS) or other conditions that affect walking.

The L300 Go System is approved to help adults and children with foot drop, and to assist adults with knee flexion or extension problems caused by muscle weakness related to upper motor neuron disease or injury. It is the first electrical stimulation device to offer 3-D motion detection of gait and muscle activation.

Gait disorders, such as foot drop or knee instability, are frequently linked to upper motor neuron diseases such as MS, or to brain and spinal injuries.

Electrical stimulation of leg muscles helps MS patients who struggle with ankle and knee flexing to walk with greater ease, and possibly lower their risk of falling.

The mobile app — which is expected to be released shortly — helps to control the L300 Go System, allowing users to change between stimulation models, gait and training, as well as to adjust pre-determined intensities to fit their daily rehabilitation needs.

It offers users the ability to track activity, set personal goals, and review progress over time.

The L300 Go System uses data from a three-axis gyroscope and accelerometer to generate 3-D motion detection of gait events and muscle activation. The system monitors patient movement and applies electrical stimulation as needed during the gait cycle. The system uses an adaptive algorithm that works with a high-speed processor, capable of detecting changes in gait dynamics within 10 milliseconds, the company reports.

“Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility,” Todd Cushman, president and chief executive officer of Bioness, said in a press release.

The L300 Go System is already available; Bioness plans to release the myBioness mobile app this spring, initially for use by iOS mobile devices.

Ed Tobias, a Multiple Sclerosis News Today columnist, discussed the L300 Go System — an upgrade on the L300 system that he has used for years — in a recent column titled, “FAQs About the Bioness ‘L300 Go’ for Foot Drop.”