The U.S. Food and Drug Administration (FDA) approved the ReWalk exoskeleton, which helps paraplegics walk again, on Thursday.
Before Thursday's announcement, not everyone in the U.S. was able to buy ReWalk, according to CNET. But now, people in the country with spinal cord injuries can use the device to stand upright, walk, and turn while also using crutches.
"Innovative devices such as ReWalk go a long way towards individuals with spinal cord injuries gaining some mobility," said Christy Foreman, director of the Office of Device Evaluation for the FDA's Center for Devices and Radiological Health. "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."
The FDA said there are almost 200,000 people in the U.S. that have spinal cord injuries, and many of them are partially or completely paraplegic.
ReWalk was tested in a clinical trial in which 30 participants tested its ability to walk on different surfaces. The time it took for users to travel certain distances was also tested, Engadget reported.
The FDA used these tests to determine who could buy and use the seven-pound exoskeleton. Only people who currently use crutches and stand with assistance will be able to purchase the device.
ReWalk was created by Amit Goffer, who became a paraplegic in 1997, following an ATV accident. The accident motivated Goffer to develop mobility devices that could help people with spinal cord injuries. The device was made by Argo Medical Technologies, CNET reported.
Since its creation, the exoskeleton has been used by hundreds of people, including Claire Lomas, a paralyzed British woman who used it to walk in the London marathon in 2012, and Derek Herrera, a captain in the U.S. Marine Corps who used it to walk again. Herrera will be one of the first U.S. citizens to own the device.
"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. "It will be incredible for me to regain independence, to use the system to walk and stand on my own."
ReWalk, which received approval in the European Union in 2012, had previously only been approved in the U.S. for rehabilitation centers. The exoskeleton is priced at $70,000, and is expected to have around the same price in the EU.
"This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries," said Larry Jasinski, CEO of ReWalk Robotics. "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."
