Lightweight Robotic Exoskeleton Approved By FDA

The Indego robotic exoskeleton has received approval from the FDA. The device, which is 26 pounds and designed to be easy to put on and take off from a wheelchair, was tested in an extensive clinical trial, assessing its safety on a variety of indoor and outdoor surfaces.

“It is particularly gratifying because it is the first thing that has come out of my lab that has become a product that people can purchase, which hopefully will make a significant improvement in their quality of life,” Vanderbilt engineering professor Michael Goldfarb said in a statement.

Indego is strapped tightly around the torso, with rigid supports attaching to the hip, knee, and foot. Battery-powered, computer-controlled electric motors drive the joints, and the wearer navigates the device similar to a Segway, according to the engineers. Lean forward and the exoskeleton walks forward, lean back for a while and it will sit down.

Indego, which has been available in Europe since November, is the second exoskeleton to gain FDA approval in the U.S. The first, ReWalk was approved in 2014. Indego’s selling point is its weight–almost 20 pounds lighter than ReWalk–and its functional electrical stimulation, which sends little electrical pulses to the paralyzed muscles. Those pulses could help lessen muscle atrophy and improve circulation. Now, Parker Hannifin, the manufacturer, needs to show that the device can reduce the secondary medical conditions often caused by lower-body paralysis, in order to convince insurance companies to cover the $80,000 device. According to the Wall Street Journal, the company plans a commercial launch for Indego in the U.S. “in the coming months.”