Berkeley, Calif-based bionic suit designer and creator, Ekso Bionics recently announced that it has received CE Marketing Certification for its medical devices. An Ekso news release notes that moving forward, all medical devices produced by Ekso Bionics will be certified in more than 30 European Union and EFTA countries. The company received Full ISO 13485 Quality Management System and CE Marketing Certification from the British Standards Institution (BSI), a European certifier and Medical Device “Notified Body.”
The release adds that European rehabilitation facilities have already placed orders for the company’s battery-powered bionic suit, the Ekso, designed to accommodate patients with spinal cord injuries (SCIs), lower-limb weakness/paralysis, and pathologies that inhibit their ability to walk.
Eythor Bender, Ekso Bionics CEO, characterizes the certification as a big step towards expanding Ekso’s availability, “For all of us, walking is a basic need and it shows in the strong demand for Ekso in the US where it has been available for 3 months…we decided early on this journey to focus on the relatively small but challenging spinal cord injury 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,” Bender explains. Bender adds that the company is on track to release a personal version of the Ekso within 24 months.
Andy Hayes, director of Ekso Bionics, Europe notes that the rollout in Europe has received a warm reception, “We are already shipping Eksos and starting customer training next week,” Hayes says.
The release reports that the first neurological rehabilitation hospital slated to receive the Ekso is Prosperious Tiberino Rehabilitation Clinic, Tuscany, Italy.
Source: Ekso Bionics