FDA Clears First of Robotic Exoskeleton for Multiple Sclerosis

The US Food and Drug Administration (FDA) has cleared the first exoskeleton device for use in the rehabilitation of patients with multiple sclerosis (MS).

The FDA cleared the wearable EksoNR robotic exoskeleton, from Ekso Bionics Holdings, in 2016 for use in stroke and spinal cord injury rehabilitation and in 2020 for use in acquired brain injury (ABI).

According to the company, the EksoNR builds on its predecessor, the Ekso GT, and represents the “next-generation” gait-assist lower-body powered exoskeleton for physical and neurorehabilitation.

“As a leader in early-to-market wearable robotic solutions for medical rehabilitation, we are committed to maximizing patient access to our technology,” Steven Sherman, chairman and CEO of Ekso Bionics, said in a news release.

“With the indications for use now expanded to include MS, the EksoNR has the potential to assist significantly more patients and improve patient mobility,” said Sherman.

“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,” he added.

According to the company, Ekso devices are in use by more than 375 rehabilitation centers worldwide and have helped patients take nearly 200 million steps while supporting patients’ hopes of mobility and independence.

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