ReWalk Robotics files for exoskeleton suit clearance
ReWalk Robotics’ exo-suit designed for stroke rehabilitation.
ReWalk Robotics (NSDQ:RWLK) said it has applied to FDA for 510(k) clearance of its ReStore exoskeleton suit for gait training during stroke rehabilitation.
The Yokneam, Israel-based company designed its exo-suit to provide coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. It recently won insurer reimbursement from Cigna and completed a clinical trial involving 44 patients at five rehabilitation centers in the U.S.
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The post ReWalk Robotics files for exoskeleton suit clearance appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Nancy Crotti Tags: 510(k) Blog Business/Financial News Food & Drug Administration (FDA) Neurological News Well Regulatory/Compliance Robotics ReWalk Robotics Source Type: news
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