Russian medical equipment manufacturer ExoAtlet has received official approval from the US Food and Drug Administration (FDA) to export medical exoskeletons (wearable devices designed to help people with locomotor disabilities walk again) to the US market, RIA Novosti reports.
“The certification confirms compliance with the norms and standards of national legislation and opens up an opportunity for the company’s products to enter the American market,” the manufacturer said.
It is noted that ExoAtlet manufactures its exoskeletons in South Korea and is headquartered in Luxembourg. Since its launch in 2015, the company’s rehabilitation devices have helped some 6,000 patients. ExoAtlet’s exoskeletons are also being used in over 70 medical facilities across China, Portugal, Russia, South Korea, Turkey, and Vietnam.
“When using our exoskeleton, patients are able to use their leg muscles again, which improves blood circulation. As a result, their overall physical health improves, and they are feeling better mentally too,” the founder and CEO at ExoAtlet, Ekaterina Bereziy, said.
Currently, the company is working on the world’s first exoskeleton for children and adolescents, ExoAtlet Bambini. Earlier this year, the model passed official registration in Russia and is already helping children with cerebral palsy.