Wandercraft, the developer of the world's first self-balancing robotic exoskeleton that enables people with limited mobility to stand up and walk again, announced today that it has received FDA clearance for Atalante X for rehabilitation in individuals with spinal cord injuries (SCI) at levels T5 to L5.
Today’s clearance is supported by safety and effectiveness data of Atalante X in patients with SCI at levels T5-L5 and has been evaluated in more than 500 patients, including clinical1 trials and real-world evidence.
The FDA’s previous clearance of Atalante X for cerebrovascular accident (CVA) in December 2022, combined with the recent unveiling of their Personal Exoskeleton designed to one day replace the wheelchair, further validates the potential of Wandercraft’s technology and their momentum as a growing force in the global medical device market.
Atalante X is the only FDA cleared exoskeleton with a powered ankle mechanism that can perform complex ankle movements that mimic a natural human gait. The unique ankle motion, combined with intelligent self-balancing technology, means that patients can experience the benefits of once-again walking in a rehabilitation setting.
Wandercraft’s approach means that therapists can now help even more patients:
- stand up and walk in the exoskeleton, on their very first session
- take steps in different directions (e.g., forwards, backwards, sideways)
- practice standing in an upright and weight-bearing positions
- more easily transfer in and out of the device
The team behind Wandercraft believes everyone should have the opportunity to stand-up and walk in their everyday lives. Wandercraft looks forward to continued testing, clinical trials, and working with regulators to bring the benefits of robotics to the rehabilitation and personal use market.
