Robotics milestone: FDA clears motorized exoskeleton to help paralyzed patients walk
A motorized exoskeleton designed to help some of the 200,000 people in the U.S. with lower body paralysis has won clearance from the FDA to market the device in the U.S., according to a company and FDA statement. ReWalk Robotics’ device is designed to help people with spinal cord injuries stand upright and walk.
ReWalk uses a fitted, metal brace that supports the legs and part of the upper body. Motors provide movement at the hips, knees, and ankles. There’s also a tilt sensor and a backpack that contains the computer and power supply. The idea is that by getting people out of their wheelchairs, users can lead healthier lives. Some of the risk factors associated with paralysis over time includes hypertension, blood clots and respiratory problems.
Users need functioning hands, arms and shoulders, as well as the ability to stand. They’re also required to get their physicians’ approval.
Dr. Amit Goffer, the CTO, invented the technology and founded the company, which was previously named Argo Robotics. He developed the device after he became a quadriplegic in an ATV accident. He served as the CEO until 2012.
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Christy Foreman, director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health, said in a statement: “Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility…. 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.”
In addition to ReWalk for personal use, the company’s ReWalk Rehabilitation system is used in the clinical rehabilitation environment for exercise and therapy and as a training base for individuals to be certified so they can purchase the personal system.
The development fits in with a broader trend of companies developing robotics and exoskeletons to accomplish different goals from carrying more weight to a means of rehabilitation.
The FDA is requiring ReWalk to do a post-market clinical study that will consist of a registry to collect data on adverse events tied to the device.
The company is looking for strategic partners that can provide customer support and manufacturing capacity.
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Read more: http://medcitynews.com/2014/06/robotics-milestone-fda-clears-motorized-exoskeleton-help-lower-body-paralysis-patients-walk/#ixzz35yYz1VQN