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

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.”

 

Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

10 comments

  1. Steve says:

    Wow, what a pointless article. They forgot to mention that the actual device is NOT FDA approved. At $5000, it’s all but unaffordable to most patients. So, we can use the app for a device we can’t afford to own. Brilliant

    • Mary Ann Cincinnati says:

      I spent $6,000 on it yrs ago. Total waste of money, and it sits in my closet to this day! I think it’s crap that they wouldn’t take it back after a few months and give me some of my money back, and sell it as a refurbished product. Guess they think money grows in trees.

  2. Julie Lyons says:

    I have used the Bioness Legacy foot drop system and now the new Bioness GO foot drop system for a little over a year now. I find it an invaluable tool that has enabled me to continue my work and ambulation. I still need the use of a cane or for much longer distances a walker. The training program is a great tool as part of the system.
    Having said all this I do feel it is important to have a clinician/ Physcial Therapist experienced with the Bioness to help you learn to use it. There is a learning curve for both the user and the device. One should initially have a trial or test with a Bioness Clinical Representative to make sure it is an appropriate device for you before pursuing insurance or self purchase. My insurance did cover the cost.

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