Russian medical gear 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 chance for the corporate’s merchandise to enter the American market,” the producer stated in an announcement on Thursday.
The corporate sees enormous potential within the US exo-rehabilitation market. In response to its evaluation, greater than 795,000 strokes happen within the US annually, about 4 occasions larger than the quantity seen in Russia. Additionally, round 18,000 People endure traumatic spinal twine accidents yearly, and the variety of endoprosthetic surgical procedures might attain 4 million a yr by 2030. All these procedures require lengthy rehabilitation afterward, with medical units like exoskeletons making certain quicker 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 in a position to make use of their leg muscle tissues once more, which improves blood circulation. Because of this, their total bodily well being improves, and they’re feeling higher mentally too,” Ekaterina Bereziy, founder and CEO at ExoAtlet, stated 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 system underwent quite a few checks designed to substantiate 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 at present engaged on the world’s first exoskeleton for youngsters 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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