Bioness receives FDA clearance and CE mark for the Ness H200 wireless system for hand paralysis as a result of stroke and other central nervous system disorders


On 4 October, Bioness announced that it has received 510(k) clearance from the FDA and CE mark approval for its Ness H200 wireless hand rehabilitation system. This new wireless system allows patients to better integrate the Ness H200 into daily life, increasing therapy time which may lead to increased patient compliance and better outcomes.

The Ness H200 wireless is an advanced hand rehabilitation system designed to use mild functional electrical stimulation 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 such as stroke, traumatic brain injury or spinal cord injury. The device is intended to provide certain individuals with hand paralysis the ability to grasp and release objects while performing ordinary and essential activities of daily living.

“It is well known in rehabilitation that frequency of therapy and training has a direct impact on outcomes. Simply put, the more patients are able to be active and integrate therapy into their day to day lives, the better their outcomes,” said Todd Cushman, senior vice-president of Global Business Development and Marketing for Bioness.

The device consists of three components: a wireless, lightweight and comfortable functional stimulation support (orthosis); 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 improve hand activity or range of motion.

The company anticipates the Ness H200 wireless will become commercially available to neurorehabilitation hospitals and centres in the USA and Europe, and to consumers for home use, later this year.