Russian medical tools producer ExoAtlet has obtained official approval to export medical exoskeletons – wearable units designed to assist folks with locomotive disabilities stroll once more – to the US market.
The US Meals and Drug Administration (FDA) this week issued an official certificates for the agency’s flagship exoskeleton for adults, ExoAtlet II, permitting it for use in the USA for medical rehabilitation.
“The certification confirms compliance with the norms and requirements of nationwide laws and opens up a possibility for the corporate’s merchandise to enter the American market,” the producer mentioned in an announcement on Thursday.
The corporate sees big potential within the US exo-rehabilitation market. In accordance with its evaluation, greater than 795,000 strokes happen within the US annually, about 4 instances increased than the quantity seen in Russia. Additionally, round 18,000 Individuals endure traumatic spinal wire accidents yearly, and the variety of endoprosthetic surgical procedures might attain four million a yr by 2030. All these procedures require lengthy rehabilitation afterward, with medical units like exoskeletons guaranteeing sooner restoration and social adaptation.
ExoAtlet manufactures its exoskeletons in South Korea and is headquartered in Luxembourg. Since its launch in 2015, the corporate’s rehabilitation units have helped some 6,000 sufferers.
“When utilizing our exoskeleton, sufferers are ready to make use of their leg muscle tissue once more, which improves blood circulation. Because of this, their general bodily well being improves, and they’re feeling higher mentally too,” Ekaterina Bereziy, founder and CEO at ExoAtlet, mentioned in a current interview.
ExoAtlet II has additionally obtained medical certifications in Europe, South Korea and Russia, which acknowledged the mannequin as assembly “the excessive necessities of security, well being and environmental safety.” As a part of the certification course of, the machine underwent plenty of exams designed to verify its load capability, sturdiness and security. ExoAtlet’s exoskeletons are being utilized in over 70 medical amenities throughout China, Portugal, Russia, South Korea, Turkey and Vietnam.
The corporate is presently engaged on the world’s first exoskeleton for kids and adolescents – ExoAtlet Bambini. Earlier this yr, the mannequin handed official registration in Russia and is already serving to kids with cerebral palsy, RIA Novosti studies.
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