The FDA has approved the ReWalk exoskeleton for sale in the US

TECHi's Author Louie Baur
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Louie Baur
Louie Baur
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The motorized exoskeleton that Claire Lomas wore during her historic marathon walk may soon be available for purchase in the United States. As of yesterday, the US Food and Drug Administration has cleared the ReWalk system for marketing. Designed to assist those suffering from spinal cord injuries, the bionic suit allows its wearers to stand, walk, and navigate stairs with limited assistance. “Along with physical therapy, training, and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities,” FDA’s Office of Device Evaluation director Christy Foreman says in a statement.

Cnet

Cnet

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The ReWalk exoskeleton has helped countless paraplegics be able to walk again. But, until now, not just anybody in the US could buy one. That’s because the US Food and Drug Administration hadn’t given full approval for its use. However, the government announced Thursday that ReWalk has finally won FDA clearance. “Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” Christy Foreman, director of the Office of Device Evaluation for the FDA’s Center for Devices and Radiological Health, said in a statement. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.” According to the FDA, about 200,000 people in the US have spinal cord injuries, many of whom have partial or complete paraplegia. ReWalk exoskeletons work by attaching a wearable motorized brace to users, which they can control with a computer and motion sensors. This system lets paraplegics independently stand upright, turn, and walk, while also using crutches. Such movement gives people with spinal cord injuries added health benefits such as cardiovascular improvements, loss of fat tissue, and muscle gain.

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