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February 8, 2017

Bioness secures FDA clearance for L300 Go system to diagnose gait

Medical technology company Bioness has secured the US Food and Drug Administration (FDA) clearance for the use of its L300 Go System to detect gait movement disorders.

Medical technology company Bioness has secured the US Food and Drug Administration (FDA) clearance for the use of its L300 Go System to detect gait movement disorders.

Equipped with 3D motion detection, multi-channel stimulation and a mobile iOS application, the L300 Go is a functional electrical stimulation (FES) system, which uses data from a three-axis gyroscope and accelerometer to identify gait events and muscle activation.

The system monitors patient movement in all three kinematic planes to provide accurate stimulation during the gait cycle.

"The system monitors patient movement in all three kinematic planes to provide accurate stimulation during the gait cycle."

It features an adaptive, learning algorithm that accommodates changes in gait dynamics and a high speed processor that deploys stimulation within ten milliseconds of detecting a valid gait event.

The home users of the system can track activity, set personal goals and review their progress over time with the dynamic reporting capabilities of the myBioness mobile iOS application.

The L300 Go multi-channel stimulation enables control of the amount of dorsiflexion and inversion / eversion provided, while the medial and lateral stimulation can be adjusted independently with the proprietary electrode.

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

Expected to launch this year, L300 Go will be initially available only for healthcare professionals and users of the firm's L300 Foot Drop System and L300 Plus System.

Bioness offers new technologies and solutions such as implantable and external neuromodulation systems, robotic systems and software based therapy programmes.

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