Ekso Bionics Holdings Inc, a provider of exoskeleton technology for medical and industrial use, announces it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EksoNR 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.
“As a leader in early-to-market wearable robotic solutions for medical rehabilitation, we are committed to maximizing patient access to our technology,” said Steven Sherman, Chairman and Chief Executive Officer of Ekso Bionics. “With the indications for use now expanded to include MS, the EksoNR has the potential to assist significantly more patients and improve patient mobility. We are excited to see the device benefit MS patients, providing critically needed rehabilitation solutions just as it has for patients suffering from stroke, spinal cord injury and acquired brain injury.”
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.
[Source(s): Ekso Bionics Holdings Inc, GlobeNewswire]
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