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October 6, 2011

FDA, European commission clears Bioness wireless hand paralysis device

Bioness has received US Food and Drug Administration (FDA) and CE mark approval for its NESS H200 wireless hand rehabilitation system.

Bioness has received US Food and Drug Administration (FDA) and CE mark approval for its NESS H200 wireless hand rehabilitation system.

The NESS H200 is designed to use mild functional electrical stimulation (FES) to improve hand function and promote motor recovery in patients who have lost function of their upper extremity following injury to the central nervous system.

The new wireless system will provide hand paralysis individuals the ability to grasp and release objects while performing ordinary and essential activities of daily living.

The device incorporates a wireless, lightweight functional stimulation support, a small handheld control unit that communicates wirelessly with the system and a clinician’s programmer that allows for easy programming and patient activity tracking.

Designed for use in both the rehabilitation setting and the home, the NESS H200 Wireless may reduce muscle spasm, prevent muscle atrophy, reeducate muscles, increase local blood circulation and may also improve hand activity or range of motion.

NESS H200 Wireless will be commercially available to neurorehabilitation hospitals and centres in the US and Europe, later in 2011.

 

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