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.

”This submission marks a significant milestone for robotic rehabilitation technologies and represents a clear, distinct evolution in powered rehabilitation solutions,” said ReWalk CEO Larry Jasinski in a prepared statement. “The ReStore is a versatile device which will provide high-level, reproducible care for a broad range of a clinic’s gait training clients, at a price point accessible to many more clinics than current technologies.”

The company said last year it intends to offer the exo-suit for less than $20,000. ReWalk applied for CE clearance in 2018 and expects to begin selling the ReStore device in Europe in mid-2019. Pending FDA clearance, the company said it could launch the product in the U.S. in the late second quarter or third quarter of this year.

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