Robotic walking assistant for paraplegics obtains CE mark
The Ekso “wearable” robot from Ekso Bionics, with whose help paraplegics are able to stand and walk again, has qualified to carry the European CE mark. The safety and quality of the orthosis was confirmed when the US FDA approved the apparatus at the start of this year.
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Since then, exhaustive testing in collaboration with physiotherapy clinics has taken place in the United States. The British Standard Institute has meanwhile certified the quality management system at Ekso Bionics according to EN ISO 13485 and provided the basis for the CE labelling.
Only in hospitals initially
“The Ekso is now ready for delivery to hospitals in Europe and throughout the world,” says Andy Hayes, managing director of Ekso Bionics Europa. “For us, therapeutic benefit for patients and device safety are at the forefront, which is why we are initially continuing to focus on the device’s use in physiotherapy clinics and hospitals.”
Variant for home use coming
The first hospitals in Europe to receive the wearable robot are Instituto Prosperius in Umbertide, Italy, and Sheffield Northern General Hospital in the UK. Hayes continues: “Every Ekso is accompanied by a detailed training programme and a package of comprehensive services. All findings from the use of the Ekso and the knowledge of experts working in the field of neurology and spinal cord injuries are going to go toward developing a variant of the Ekso for use at home. We are planning to introduce this model on the market in spring 2014.”
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