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Argo Preps 510(k) Application For ReWalk Exoskeleton For Home Use

The firm launched the CE-marked, first-of-its-kind device for personal home use in Europe in early September at the International Spinal Cord Society meeting in London.

Argo Medical Technologies is preparing to submit a 510(k) application to FDA in the near future for home use of its ReWalk exoskeleton system, intended to enable people with lower-limb disabilities, such as paraplegia, to stand and walk independently. The firm hopes to gain U.S. market go-ahead in the first half of 2013.

Designed as an alternative to wheelchairs to provide mobility and aid performance of routine activities, ReWalk “is a cutting-edge device...

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