ReWalk Shares Surge On FDA Breakthrough Device Tag For Orthotic Exo-Suit

  • The FDA has granted Breakthrough Device designation to ReWalk Robotics Ltd's RWLK ReBoot device.
  • The ReBoot is a lightweight, battery-powered orthotic exo-suit intended to assist ambulatory functions in individuals with reduced ankle function related to neurological injuries. 
  • The ReBoot is a customizable personalized device intended for home and community use. 
  • The ReBoot works in conjunction with the muscles of the affected leg to assist individuals with maintaining safe foot positioning and pushing off the ground, which means it may improve their gait.
  • With this designation, ReWalk will now readily pursue the FDA approval pathway for ReBoot. 
  • The company is finalizing ReBoot's design and development and will proceed to the clinical studies required for FDA clearance application.
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: RWLK shares are up 52.7% at $1.97 during the premarket session on the last check Friday.
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