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NAMSR News: FDA Allows First Medical Device That Allows Paraplegics to Walk
FDA allows marketing of first wearable, motorized device that helps people with certain spinal cord injuries to walk.
ReWalk has been used in rehabilitation hospitals in the United States for several years and available publicly in Israel, the United Kingdom, and several other European countries. Now it’s available for personal use in the United States, after a recent approval from the Food and Drug Administration.
This means that any disabled person will be able to purchase one, as an alternative to a wheelchair. Several other companies are working on similar devices, but ReWalk is the first to get general FDA approval, and Herrera plans to be the first American to purchase one.
The entire ReWalk rig weighs about 44 pounds. This includes the motorized leg braces, and a backpack that contains a control computer and a couple of lithium-ion batteries to provide up to four hours of mobility.
ReWalk consists of a fitted metal brace that supports the legs and part of the upper body; motors that supply movement at the hips, knees, and ankles; a tilt sensor; and a backpack that contains the computer and power supply. Crutches provide the user with additional stability when walking, standing, and rising from a chair. Using a wireless remote control worn on the wrist, the user commands the ReWalk to stand up, sit down, or walk.
To assess safety and effectiveness of ReWalk, the FDA reviewed testing done to assess ReWalk’s durability, its hardware, software and battery systems, and other safety systems that help minimize risk of injury should the device lose balance or power.
The FDA also reviewed clinical data based on 30 study participants. The clinical tests assessed the participants’
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