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Wandercraft's Self-Balancing Exoskeleton Receives Second FDA Clearance for Spinal Cord Injury Rehabilitation

Wandercraft has recently announced that its Atalante X robotic exoskeleton has received FDA clearance for use in rehabilitating individuals with spinal cord injuries (SCI) at levels T5 to L5. This clearance comes after extensive safety and effectiveness evaluations involving over 500 patients, encompassing clinical trials and real-world evidence.

The Atalante X exoskeleton is notable for being the only FDA-cleared device of its kind equipped with a powered ankle mechanism capable of replicating complex ankle movements resembling natural human gait. This feature, coupled with sophisticated self-balancing technology, allows patients to experience the sensation of walking again during rehabilitation sessions.

Wandercraft's innovative approach enables therapists to assist a wider range of patients by facilitating:

  • Standing up and walking in the exoskeleton from the initial session.
  • Taking steps in various directions, such as forwards, backwards, and sideways.
  • Practicing upright, weight-bearing positions.
  • Facilitating easier transfer in and out of the device.

The FDA's approval of Atalante X for spinal cord injury rehabilitation represents a significant advancement in robotics and rehabilitation research. It creates opportunities to explore the optimal utilization of this advanced exoskeleton in addressing mobility challenges resulting from spinal cord injuries. This expanded indication holds promise for improving the quality of life and functional independence of individuals with SCI.

Source: https://www.wandercraft.eu/articles/wandercrafts-self-balancing-exoskeleton-receives-second-fda-clearance

 

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