B-Temia announced today that it received FDA 510(k) clearance for its Keeogo Dermoskeleton human mobility system.
Short for “keep on going,” Keeogo is a lower-limb-powered human mobility device with Dermoskeleton lightweight exoskeleton technology that provides what the Quebec City-based company describes in a news release as a “true human-machine interface.”
The Keeogo Dermoskeleton is designed to detect, respond to and support an individual’s movements with advanced software and motorized assistance. Based on individual needs, it offers mobility assistance, including complimentary knee strength and movement cues.
B-Temia’s system is intended for use by stroke patients who fit the user assessment criteria in rehabilitation settings under the supervision of healthcare professionals.
“The work we have accomplished since 2019 paved the way to this achievement,” B-Temia CEO Stéphane Bédard said in the release. “This is a major milestone for B-Temia. I am tremendously proud of our team since they were able to manage many challenges during the process to ensure that we reach our corporate objective. Keeogo is a true disruptive product, with no comparable around the world, which made the alignment with the FDA challenging.
“This U.S. market clearance is the biggest milestone of our global regulatory expansion, as the U.S. is the largest medical device market. It also gives us great confidence for the other regulatory approvals we are currently completing for additional territories.”