Zurich – Magnes AG has received CE marking MDR Class IIa certification for its NUSHU Smart shoes. The sensor-equipped shoes have been developed for the treatment of neurological disorders.
The Zurich-based medical technology company Magnes AG has been classified as a Class IIa medical device under the European Medical Device Regulation (MDR) for its shoes equipped with innovative sensor technology, according to a post on LinkedIn. The intelligent NUSHU shoes enable clinical gait analysis of patients in real time and provide patients with direct vibrotactile bio-feedback based on their gait, according to a press release. The vibrations are intended to support patients when walking. NUSHU uses intelligent sensors and artificial intelligence algorithms to provide clinical-grade gait analysis, both in clinics and in remote environments, according to the press release. This enables clinics to offer personalized, effective disease management and rehabilitation programs.
Having already registered the product with the US Food and Drug Administration (FDA) last year, Magnes says this CE certification will enable it to offer the benefits of NUSHU to patients and physicians across Europe and the US. The CE certification is "an important milestone for our company", CEO Olgaç Ergeneman is quoted as saying. Magnes will continue its "research and development activities to deliver innovative solutions to the challenges patients face every day".
Magnes is a spin-off of the Swiss Federal Institute of Technology in Zurich (ETH) and focuses on the research and development of algorithms for analyzing human movement and embedded systems that enable real-time bio-feedback. ce/gba
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