B-Temia’s Keeogo exoskeleton has received 510(k) clearance from the U.S. Food & Drug Administration.

In a Sept. 14 news announcement, B-Temia said the clearance “opens the largest medical device market in the world.”

Stéphane Bédard, B-Temia’s CEO, called the process of receiving 510(k) clearance “challenging” because of Keeogo’s uniqueness.

“The work we have accomplished since 2019 paved the way to this achievement,” Bédard said. “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.”

The Keeogo exoskeleton — whose name is a shortened form of the phrase “Keep on going” — is described by B-Temia as a lower-limb, powered mobility device that can be used during rehabilitation or as a personal assistance device. Thanks to smart features, the Keeogo “detects, responds, and then supports an individual’s movements with advanced software and motorized assistance,” B-Temia said. Applications include improving strength and providing support during exercise; facilitating more even steps to improve gait training; and stabilizing the knee to improve mobility and reduce pain.

B-Temia lists potential consumers as those diagnosed with stroke, brain injury, spinal cord injury, knee osteoarthritis, multiple sclerosis, Parkinson’s disease, muscular dystrophy, myositis, and various musculoskeletal injuries.

A physical therapist speaking in a Keeogo testimonial said that clients who use the exoskeleton at home can engage in much more frequent gait training than what they’d typically receive from going to clinic once a week. The more consistent gait training can also motivate clients once they start noticing improvements.

B-Temia is headquartered in Québec City, Québec.