The motorized exoskeleton that Claire Lomas wore during her historic marathon walk may soon be available for purchase in the United States. As of yesterday, the US Food and Drug Administration (FDA) has cleared the ReWalk system for marketing.
first-of-its-kind medical devices
Designed to assist those suffering from spinal cord injuries, the bionic suit allows its wearers to stand, walk, and navigate stairs with limited assistance. "Along with physical therapy, training, and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities," FDA's Office of Device Evaluation director Christy Foreman says in a statement.
Prior to issuing its approval, the governmental agency subjected ReWalk through its de novo classification process, which is used for "first-of-its-kind medical devices." Additionally, the FDA reviewed ReWalk's durability, hardware, software, and battery systems, along with clinical data from 30 participants. Manufacturer Argo Medical Technologies is also required to submit a post-market clinical study, detailing data on "adverse events" and the performance of its training programs. CNET writes that ReWalk may cost about $70,000, mirroring its price in Europe, where it is already available.