Last week I wrote about the de novo regulatory pathway, and how to determine whether it's the right choice for your device. As discussed in that post, a device should be both novel and considered low or moderate risk to go that route: the ReWalk exoskeleton is a great example of a device that was both, and that was successful getting to market via the de novo pathway.
In the company's own words, "ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury (SCI) to stand upright, walk, turn, and climb and descend stairs*. ReWalk is the first exoskeleton to receive FDA clearance for personal and rehabilitation use in the United States. *Stair function not currently available in US".
The ReWalk goes beyond the major quality of life issues that come to mind when helping paralyzed people be more ambulatory and independent: it also has a therapetuic effect in bettering circulation, muscle tone, digestion, which are all issues with paralysis. In the words of Dr. Ann Spungen in the third video below, "All the terrible things that go wrong from a sedentary lifestyle are magnified in a person with a spinal cord injury. So any activity we can provide for them, it stands to reason to have benefits."
As I mentioned in last week's post, you can view summary documents of devices that have been approved via the de novo pathway here. ReWalk's decision summary (Evaluation of Automatic Class III Designation (de novo)) is here, and their Classification Order is here.