VALENCIA, Calif.--(BUSINESS WIRE)-- Bioness Inc. today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its L300 Foot Drop System to pediatric patients and their caregivers. This is the first FDA cleared neurostimulation device of this kind for use with children. The L300 is a neuromodulation technology designed to treat foot drop, a condition which causes walking difficulty in adults and pediatrics with upper motor neuron pathologies. Bioness will be showcasing the system and its use in pediatrics at the American Physical Therapy Association (APTA) conference this week in San Diego. More than 500,000 Americans suffer from the effects of cerebral palsy (CP), in addition to the large number of children affected by foot drop as a result of traumatic brain injury, stroke and other conditions. For these children, mobility can be a daily struggle, and result in having difficulty with many of the activities most of us consider essential to childhood," said Dr. Michael Armento, pediatric physiatrist, Childrens Specialized Hospital, the nations largest provider of pediatric rehabilitation services.Having another potential intervention to offer children and families impacted by foot drop opens up the opportunity for us to not only promote physical development, … Continue reading
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