Ekso Bionics, designer and creator of exoskeletons -- bionic suits -- that physically augment humans, today announced that it has received CE Marking Certification. Henceforth, all medical devices produced by Ekso Bionics will be certified in over 30 European Union and EFTA countries. European rehabilitation facilities are already placing orders for the company's newest bionic suit, Ekso, which will be shipped to them in the coming weeks. Ekso is a wearable robot that powers wheelchair users up, enabling them to stand and walk. The suit fulfilled the FDA requirements earlier this year, which has enabled the company to partner with and sell Ekso to top rehabilitation centers in the United States, including the Rehabilitation Institute of Chicago, Kessler Foundation, TIRR Memorial Hermann, Craig Hospital, and Spaulding Rehabilitation Hospital, among many others.
Ekso is a ready-to-wear, battery-powered bionic suit designed for users with spinal cord injuries, lower-limb weakness/paralysis and pathologies that inhibit their ability to walk. It is strapped over the user's clothing. The user doesn't bear the weight however, as the suit transfers its 45 lb. (20 kg) load directly to the ground. Each Ekso can be adjusted in a few minutes to fit most people weighing 220 pounds (100 kg) or less, and standing between 5'2" and 6'2" (157cm to 188cm), with at least partial upper body strength, and can be adjusted to fit one user and then another in minutes. The suit provides unprecedented knee flexion, which translates into a natural four point gait, thereby allowing Ekso to be used as a gait training tool.
"Today, we have taken a big step towards making the Ekso walking experience available to anyone, anywhere," stated Eythor Bender, CEO of Ekso Bionics. "For all of us, walking is a basic need and it shows in the strong demand for Ekso in the U.S. where it has been available for 3 months. We've successfully delivered close to ten suits and are taking multiple and repeat orders from preeminent rehabilitation centers," he explained. "Bionic suits are brand new and a game-changing technology, so we decided early on this journey to focus on the relatively small but challenging Spinal Cord Injury (SCI) population. Their injuries generally occur when they are young, so they were the ideal group to collaborate with in testing and improving Ekso, prior to our product launch. We also chose to initiate our delivery service via rehabilitation centers, rather than offering it first directly to consumers, because it will ensure the product's safety as well as genuinely useful improvements. We are on track to release a personal version within 24 months," he added.
"We're buoyed by the warm reception we are experiencing in Europe. Our rollout here is happening much faster than we had expected," said Andy Hayes, director of Ekso Bionics, Europe. "We are already shipping Eksos and starting customer training next week," he commented.
The first neurological rehabilitation hospital to receive the bionic suit in Europe is Prosperius Tiberino Rehabilitation Clinic in Tuscany, Italy:
http://www.prosperius.it/ Prosperius is currently the only fully integrated rehabilitation clinic in Italy, utilizing innovative technologies for the multidisciplinary care of their clients. The first spinal cord injury center in Europe to receive an Ekso is the Princess Royal Spinal Cord Injury Centre, a renowned spinal treatment center and NHS facility in Sheffield, UK
Ekso Bionics received Full ISO 13485 Quality Management System and CE Marking Certification from the British Standards Institution (BSI), a European certifier and Medical Device 'Notified Body.' The 'CE' marking is legally required to show conformance to the Medical Device Directive, thereby enabling Ekso Bionics to market its products to over 30 European Union and EFTA countries. The ISO 13485 Standard and Medical Device Directive equivalents usually form the base device requirements of Australia, Brazil, Canada, Japan, New Zealand and the rest of the world. The sale of each bionic suit to rehabilitation centers includes "Ekso +," a comprehensive service and training program.
Ekso Bionics (http://www.eksobionics.com) -- formerly known as Berkeley Bionics and headquartered in Berkeley, California with offices in London, UK -- is a privately held designer and maker of wearable robots, or bionic suits, that physically augment humans.
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