Subject: FDA
Bioness Receives FDA Clearance for myBionesstm iOS app for mobile control of the L300 Gotm System
VALENCIA, Calif., March 26, 2018 /PRNewswire/ -- Bioness, Inc., the leading provider of cutting-edge, clinically supported rehabilitation therapies, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) for the myBionessTM mobile app for use with the L300 Gotm System.
The new myBionesstm mobile iOS application allows home users to control their L300 Go system including ability to change stimulation modes between gait and training along with adjusting personal pre-set intensities to meet their daily activity demands. The app has been designed to keep users engaged in the rehabilitation process and motivated to meet their recovery goals with ability to track activity, set personal goals and review their progress over time using dynamic reporting capabilities.
Gait movement disorders, such as foot drop and knee instability, are often associated with an upper motor neuron disease such as stroke and multiple sclerosis as well as injuries to the brain and spinal cord. Individuals with an impaired gait have less control over their lower extremity muscles and are at an increased risk for falls. The L300 Go is the first functional electrical stimulation (FES) system to offer 3D motion detection of gait events and muscle activation using data from a 3-axis gyroscope and accelerometer. Patient movement is monitored in all three kinematic planes and stimulation is deployed precisely when needed during the gait cycle. An adaptive, learning algorithm accommodates changes in gait dynamics, and a high speed processor that deploys stimulation within 10 milliseconds of detecting a valid gait event. This rapid, reliable response is critical and supports user confidence.
"Technological innovations including 3D motion detection and multi-channel stimulation work together to improve treatment efficiency and promote patient mobility," said Todd Cushman, President and CEO of Bioness. "At Bioness, we are focused on improving the lives of patients through technology and are proud to add the myBioness mobile application to the L300 Go portfolio of products."
The L300 Go System was cleared by the U.S. Food and Drug Administration on January 27, 2017 with formal approval of the upgraded mobile application clearance dated March 9, 2018. The system is indicated to provide 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 (e.g., stroke, damage to pathways to the spinal cord). The L300 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.
Bioness will begin commercial release of the myBionessTM mobile app in the spring of 2018. The L300 Go Systems are commercially available since the summer of 2017.
About Bioness, Inc.
Bioness is the leading provider of innovative technologies helping people regain mobility and independence. Bioness solutions include implantable and external neuromodulation systems, robotic systems and software based therapy programs providing functional and therapeutic benefits for individuals affected by pain, central nervous system disorders and orthopedic injuries. Currently, Bioness offers six medical devices within its commercial portfolio which are distributed and sold on five continents and in over 25 countries worldwide. Our technologies have been implemented in the most prestigious and well-respected institutions around the globe with approximately 90% of the top rehabilitation hospitals in the United States currently using one or more Bioness solution. Bioness has a singular focus on aiding large, underserved customer groups with innovative, evidence-based solutions and we will continue to develop and make commercially available new products that address the growing and changing needs of our customers. Individual results vary. Consult with a qualified physician to determine if this product is right for you. Contraindications, adverse reactions and precautions are available online at www.bioness.com.
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SOURCE Bioness, Inc.
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