The first robotic device that acts as legs to help paraplegics walk has been cleared for sale by US regulators.
The device, called ReWalk, is a motorised "exoskeleton" approved for those whose lower body is paralysed from a spinal cord injury.
ReWalk has been available in Europe since 2012.
The product, made by Argo Medical Technologies, consists of a fitted, metal brace; motors at the hips, knees and ankles; and a backpack that contains the computer and power supply.
ReWalk weighs 21kg, only 2.3kg of which users feel from the backpack, according to Argo, based in Marlborough, Massachusetts. The personal system costs US$69,500, the company said.
"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 we have observed in clinical trials," Larry Jasinski, Argo Medical's chief executive officer, said.
Patients use crutches to provide additional stability and a remote control on their wrist to command ReWalk to stand, sit or walk, the FDA said. The device is custom-fitted for each user, and patients and their caregivers must undergo training to use the product.
The device was developed by Argo Medical founder Amit Goffer in 2001 after he was paralysed in an accident with an all-terrain vehicle, according to the company.
The Food and Drug Administration cleared ReWalk through its process for novel devices that are considered low- to moderate-risk. Patients should not use the device if they have a history of severe neurological injuries other than spinal cord injury or other medical issues such as infection or heart or lung conditions, the FDA said.