Russian medical equipment manufacturer ExoAtlet has received official approval to export medical exoskeletons – wearable devices designed to help people with locomotive disabilities walk again – to the US market.
The US Food and Drug Administration (FDA) this week issued an official certificate for the firm’s flagship exoskeleton for adults, ExoAtlet II, allowing it to be used in the United States for medical rehabilitation.
“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 in a statement on Thursday.
The company sees huge potential in the US exo-rehabilitation market. According to its analysis, more than 795,000 strokes occur in the US each year, about four times higher than the number seen in Russia. Also, around 18,000 Americans suffer traumatic spinal cord injuries every year, and the number of endoprosthetic surgeries may reach 4 million a year by 2030. All these procedures require long rehabilitation afterward, with medical devices like exoskeletons ensuring faster recovery and social adaptation.
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.
“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,” Ekaterina Bereziy, founder and CEO at ExoAtlet, said in a recent interview.
ExoAtlet II has also received medical certifications in Europe, South Korea and Russia, which recognized the model as meeting “the high requirements of safety, health and environmental protection.” As part of the certification process, the device underwent a number of tests designed to confirm its load capacity, durability and safety. ExoAtlet’s exoskeletons are being used in over 70 medical facilities across China, Portugal, Russia, South Korea, Turkey and Vietnam.
The company is currently 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, RIA Novosti reports.
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