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Bioness wins FDA approval for L300 Go system

MDBR Staff Writer Published 08 February 2017

Rehabilitation therapies provider Bioness has secured approval from the US Food and Drug Administration (FDA) for its L300 Go system.

The system will be used to offer ankle dorsiflexion in adult and pediatric individuals with foot drop and/or assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury.

The new system, which is based on NESS L300 foot drop system and NESS L300 Plus system, includes advanced features such as 3D motion detection of gait events, multi-channel stimulation and mobile iOS application to track user activity.

Gait movement disorders, including foot drop and knee instability, will result in upper motor neuron disease such as stroke and multiple sclerosis. It may also associated with an as injuries to the brain and spinal cord.

L300 Go is claimed to be the first functional electrical stimulation (FES) system to provide 3D motion detection of gait events and muscle activation using data from a 3-axis gyroscope and accelerometer. 

The system will monitor patient movement in all three kinematic planes, and helps to deploy stimulation precisely when needed during the gait cycle.

An adaptive and learning algorithm can accommodate changes in gait dynamics, while high speed processor will deploy stimulation within 10 milliseconds for detecting a valid gait event.

The new myBioness mobile iOS application enables home users of the system to track activity, set personal goals and review their progress over time by using enhanced reporting capabilities.

Bioness president and CEO Todd Cushman said: "Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility.

“At Bioness, we are focused on improving the lives of patients through technology and are proud to add the L300 Go into our growing portfolio of products."