Argo Medical Technologies Inc. isn’t meeting postmarket surveillance requirements for its ReWalk device, according to an FDA warning letter posted online March 1.
ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal cord injury to stand upright, walk, turn, and climb and descend stairs.
Argo didn’t get its proposed postmarket surveillance (PS) study plan for the ReWalk device approved and didn’t begin the study within the 15-month time frame, as required, the letter said.
The letter, dated Sept. 30, 2015, was signed by Jan B. Welch, then-acting director of the Office ...
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