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Ekso Bionics has acquired FDA 510(ok) clearance for its EksoNR exoskeleton. Richmond, California–primarily based Ekso Bionics designed the EksoNR know-how to be used with A number of Sclerosis (MS) sufferers.
Based on a information launch, EksoNR is the primary exoskeleton gadget to obtain FDA clearance for rehabilitation use in sufferers with MS, considerably increasing the gadget’s use to a broader group of sufferers.
The most recent era of the Ekso Bionics platform, the EksoNR beforehand acquired clearance for stroke and spinal wire rehabilitation in 2016, then acquired mind harm (ABI) in 2020. Ekso stated it was the primary of its variety to obtain a stroke indication and stands as the one exoskeleton with indications for ABI and now MS. EksoNR additionally has CE mark, the corporate stated.
“As a pacesetter in early-to-market wearable robotic options for medical rehabilitation, we’re dedicated to maximizing affected person entry to our know-how,” Ekso Bionics Chair and CEO Steven Sherman stated within the launch. “With the indications to be used now expanded to incorporate MS, the EksoNR has the potential to help considerably extra sufferers and enhance affected person mobility. We’re excited to see the gadget profit MS sufferers, offering critically wanted rehabilitation options simply because it has for sufferers affected by stroke, spinal wire harm and purchased mind harm.”
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