The approval from the FDA is for the ReWalk Personal 6.0. This is a powered exoskeleton made by the company that allows for those paralyzed from the waist down to move about with the need of a wheelchair.
While approval for the ReWalk Personal 6.0 was granted on May 26, the ReWalk Robotics news only now appears to be moving RWLK stock. The FDA approval includes the Substantially Equivalent decision, which means it is “as safe and effective as the predicate.”
Here’s a description of the ReWalk Personal 6.0 from the company’s website.
“The battery-powered system features a light, wearable exoskeleton with motors at the hip and knee joints. The ReWalker controls movement using subtle changes in his/her center of gravity. A forward tilt of the upper body is sensed by the system, which initiates the first step. Repeated body shifting generates a sequence of steps which mimics a functional natural gait of the legs.”
According to Seeking Alpha, the ReWalk Robotics news has RWLK stock trading at incredibly high levels on Monday. This sees the stock trading at volumes seven times higher than what is normal for it.
RWLK stock was up 30.6% as of Monday afternoon. However, the stock is down 46% since the start of the year.