Note Australia has an agreement facilitating the recognition of the EU CE mark within the equivalent medical registration scheme (TGA).
ReWalk Robotics, the maker of wearable robotic medical devices for individuals with lower limb disabilities, announced that its ReStore rehabilitation suit for stroke victims received CE marking, clearing its path for sale to rehabilitation clinics in the European Union.
ReStore is a soft, wearable, garment-like device that allows for a range of movement and helps facilitate patients’ functional gait training activities. The device also enables therapists to adjust and optimize a treatment.
“The ReStore revolutionizes post-stroke gait training, providing key advantage to clinics, therapists and patients,” said ReWalk CEO Larry Jasinski in a statement. ”We developed this design through collaboration with the Wyss Institute at Harvard because of the unique opportunity to combine extensive depth of the supporting science and clinician involvement in designing the ideal system for stroke therapy in the clinic.”
ReWalk said the CE mark was the first clearance for a soft exo-suit, which it called “a next-generation medical device which can serve a larger and more diverse patient population facing mobility challenges.”
ReWalk was originally founded over two decades ago by mechanical engineer Dr. Amit Goffer, who began working on an exo-skeleton frame that would allow paraplegics to regain mobility after a road accident left him paralyzed in 1998. The bionic suit has since helped people around the world regain relative independence and autonomy over their bodies.
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