Ekso Bionics Holdings, Inc. Receives FDA Clearance to Market Its Eksonr(Tm) Robotic Exoskeleton for Use with Multiple Sclerosis Patients
June 13, 2022 at 05:30 pm IST
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Ekso Bionics Holdings, Inc. announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EksoNR(TM) robotic exoskeleton for use with Multiple Sclerosis (MS) patients. EksoNR is the first exoskeleton device to receive FDA clearance for rehabilitation use in patients with MS, an indication which significantly expands the device's use to a broader group of patients. EksoNR is the latest-generation device of the most clinically used robotic exoskeleton on the market.
It was previously cleared by the FDA for stroke and spinal cord injury rehabilitation in 2016 and acquired brain injury (ABI) in 2020. The device was the first of its kind to receive a stroke indication, is the only exoskeleton with an ABI indication, and now is the first to receive an indication for MS. MS is a neurodegenerative disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Commonly diagnosed between ages 20 and 40, symptoms of MS can include neurological deficits, from vision impairment and fatigue to numbness and difficulty walking.
According to the National MS Society, there are nearly 1 million people in the U.S. living with MS and more than 2.8 million globally. Every five minutes someone is diagnosed with MS. In addition to its FDA clearances, EksoNR is CE-marked and available in Europe. Used by more than 375 rehabilitation centers globally, Ekso devices have helped patients take nearly 200 million steps, while supporting patients' hopes of mobility and independence.
Ekso Bionics Holdings, Inc. designs, develops, and markets exoskeleton products. Its exoskeleton technology serves multiple markets and can be utilized both by able-bodied persons and persons with physical disabilities or impairments. Its products include EksoNR, which is a wearable robotic exoskeleton specifically designed to be used in a rehabilitation setting; Ekso Indego Therapy is a modular, adjustable, lightweight, lower-limb powered exoskeleton; Ekso Indego Personal is a lightweight powered lower limb orthosis; Ekso Nomad is a power Knee Ankle Foot Orthosis, and Ekso EVO is a wearable upper body exoskeleton. The Company enables individuals with neurological conditions affecting gait, including acquired brain injury (ABI) and spinal cord injury (SCI), to rehabilitate and to walk again; assist individuals with a range of upper extremity impairments and allow industrial workers to perform difficult repetitive work for extended periods. Its segments include EksoHealth and EksoWorks.