ReWalk’s Momentum Continues with New Nod from FDA
ReWalk Robotics has secured a clearance from FDA for the ReStore soft exo-suit system. The Marlborough, MA and Yokneam Ilit, Israel-based company said exo-suit is intended for use in the treatment of stroke survivors with mobility challenges.
The ReStore system is comprised of a soft, garment-like design which connects to a lightweight waist pack and mechanical cables that help lift the patient’s affected leg in synchronized timing with their natural walking pattern.
The patient wears the device in a waist pack, which holds two motors, each with a cable that goes down to the foot and ankle. The cables then extend to a foot plate under the shoe. Sensors clipped to the patient’s shoes detect motion and communicate to a smart phone controller when the user needs assistance in moving the foot. Using data analytics displayed on the smart phone, a therapist can adjust the assistance level, monitor key metrics, and record standard gait-training assessments.
“The exo-suit achieves our commercial goal to offer a functional and affordable system that can be utilized in the ‘Main Street’ clinics in every community,” ReWalk CEO Larry Jasinski, said in a release. “With a launch price of $28,900 as well as leasing options, ReStore offers cutting edge innovation with features that redefine therapy at a price that is accessible for a broader range of clinics than existing robotic technologies. The current gait training reimbursement codes enable immediate penetration and sales growth as part of our pathway to become a break even and profitable company.”
ReWalk’s technology has generated significant mainstream attention, which includes being featured on an episode of the now-cancelled Glee, and being brought to the attention of former President Barack Obama back in 2013.
Original Article: (https://www.mddionline.com/rewalk%E2%80%99s-momentum-continues-new-nod-fda)