Abilitech Medical has secured a Medical Device Establishment License (MDEL) from Health Canada for the sale of its orthotic device to patients in the country.
Launched in the US last year, the company’s wearable assistive device, Abilitech Assist, is claimed to be the first and only powered orthotic device to include shoulder assistance.
It uses a combination of custom-calibrated springs, motors and firmware to provide functional independence to patients who cannot move their arms.
When wearing the external device, users will be able to lift objects weighing up to 12oz. It also supports a range of motion at the elbow and shoulder.
Abilitech and the Praxis Spinal Cord Institute collaborated last year to further scale Abilitech Assist for mass commercialisation.
Abilitech Medical founder and CEO Angie Conley said: “We’re proud to have entered the Canadian marketplace, effectively immediately.
“There are many individuals with spinal cord injuries, muscular dystrophy, multiple sclerosis and other neuromuscular disorders who will benefit from our assistive technology and are anxious to perform daily activities like eating, brushing teeth and opening doors.”
“Our device is intuitive and easy to use, can be leveraged in numerous settings and benefits families, as well as patients by lessening the burden of care.”
The hybrid system includes clinician and user-friendly adjustments, along with a slim and breathable body jacket that supports the weight of the device.
Furthermore, the lightweight, comfortable device enables patients with upper-limb weakness to use their own strength for arm movements.
With this commercial licence in place, Abilitech can now work with medical device partners within Canada.