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.
The exoskeleton, which is made by Argo Medical Technologies, was created by an Israeli inventor named Amit Goffer. He became a quadriplegic after an ATV accident in 1997, which spurred him to begin working on mobility devices for people with spinal cord injuries.
Hundreds of people have tried out ReWalk since its inception. In 2012, Claire Lomas, a paralyzed British woman, walked the London marathon using the exoskeleton. And, Derek Herrera, a captain in the US Marine Corps, was also able to walk again using the system. He will be one of the first people in the US to own ReWalk under the FDA's new clearance.
"I see this as a milestone for people in my same situation who will now have access to this technology -- to experience walking again, and all of the health benefits that come with ReWalking," Herrera said in a statement. "It will be incredible for me to regain independence, to use the system to walk and stand on my own."
Up until now, ReWalk was only approved in the US for rehabilitation centers. ReWalk was given approval in the European Union in 2012. The system costs roughly $70,000 in the EU and presumably it will cost around the same in the US.
"This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries," ReWalk Robotics CEO Larry Jasinski said in a statement. "For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits."