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The ReWalk personal system was reviewed through FDA’s de novo classification process, used for novel, first-of-its-kind medical devices that are low to moderate risk. The agency cleared the device after reviewing its durability, hardware, software, and battery system, in addition to assessing clinical data from a 30-subject study and a 16-patient observational study.
The company reports that "Study data of the ReWalk system indicate potential improvements in cardiovascular health, loss of fat tissue, building of lean muscle mass, and improved bowel function. Feedback from ReWalk users supports these potential benefits and others, such as better pain management, fewer medications, and potentially reduced hospitalizations."
The device’s manufacturer is required to complete a postmarket clinical study to collect data on adverse events related to device use and to assess the adequacy of its training program, according to the FDA.
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