US rehabilitation therapy company Bioness has received CE Mark Approval and FDA clearance for its Ness H200 Wireless system for hand paralysis patients.
The advanced wireless hand rehabilitation device uses mild Functional Electrical Stimulation (FES) to help patients to grasp and release objects while performing daily life activities.
The Ness H200 Wireless system aims to improve hand function, increase therapy time and encourage motor recovery in those suffering from hand paralysis resulting from stroke or other central nervous system disorders.
Todd Cushman, Senior Vice President of Global Business Development and Marketing for Bioness, said: “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.”
The device consists of three components: a wireless, lightweight stimulation support (orthosis); a small handheld remote that communicates wirelessly with the system; and a clinician’s programmer that allows patient activity tracking.
The company expects the equipment will become commercially available to neurorehabilitation hospitals and centres in the US and Europe, as well as to consumers for home use, later this year.
Based in California, Bioness specialises in neurostimulation devices to restore mobility and independence to people suffering from nerve damage.