Canadian medical technology firm B-Temia has secured British Standard Institute (BSI) authorisation to affix the CE marking on its powered human mobility device Keeogo.
The CE marking is expected to open new markets to commercialise its Keeogo in the 28 European Union countries and allows the registration in few Asian countries.
B-Temia president and chief executive officer Stephane Bédard said: “This is good news for us and our customers. After years working on profiling the efficacy and the safety of its hyper-innovative technology, B-Temia now has clearance to sell Keeogo on the European territory and the ability to accelerate regulatory authorizations processes in many other countries that recognize the CE marking.
“This endorsement is one of the key milestones of our global expansion plan initiated in 2017 with our Asia-based partner Wistron Corp, and therefore, it gives us great confidence for the other regulatory approvals we are currently completing for additional territories.”
CE marked Keeogo is commercially available in Canada
Keeogo, which tands for ‘Keep on going’, is designed to help people with knee osteoarthritis, muscular or neuro-degenerative conditions, spinal cord or brain injury and other injuries that impact mobility.
B-Temia has developed Keeogo, as a lower limb powered human mobility device, deploying its original Dermoskeleton technology, an advanced lightweight exoskeleton, and provides a true human-machine interface.
The technology is claimed to detect, respond and support the movements of an individual, through advanced software and motorized assistance.
The device is intended to be used as rehabilitation equipment in clinics or as a personal assistive device at home, work and in the community to aid with daily activities.
B-Temia was established in 2010 and operates as an advanced robotics tech company that develops products for the medical, industrial and military fields.
B-Temia regulatory affairs vice president Alexandre Jokic said: “The indication for use approved by the authority is the broadest and the most versatile on the exoskeleton market, prescribing that Keeogo is indicated to assist users with musculoskeletal weaknesses or lower limb instability and provides them with strength and stability to assist their ambulatory activities both in clinics and at home.”
