ABLE Human Motion receives CE Mark certification under MDR for ABLE Exoskeleton for clinical use

ABLE Human Motion, a Barcelona-based company building cutting-edge rehabilitation technology, has received the CE Mark under the new Medical Device Regulation (MDR) for its revolutionary ABLE Exoskeleton: the lightest adjustable, hip-knee-powered exoskeleton on the EU market for spinal cord injury rehabilitation. This regulatory approval enables the commercialization of the device to hospitals and rehabilitation centers across the European Union, allowing patients to improve their mobility, health and quality of life.

ABLE CE Mark

“This certificate is the culmination of 5 years of effort by an outstanding team of young, talented and passionate people who want to improve people’s lives with technology. We have had to overcome many obstacles and challenges along the way, but we never lost sight of our mission: democratizing exoskeleton technology worldwide. And today we are a bit closer for that!”, said Alfons Carnicero, CEO of ABLE Human Motion. “On such a special day we want to thank all the hospitals, patients and investors who have believed in us during this journey. Without your support we wouldn’t have made it so far!”

Spinal cord injury (SCI) is a life-changing condition that affects multiple body systems resulting in sensory and motor impairments very often associated with long-term immobility. Achieving independent ambulation has a high relevance for participation in social and professional life. Recovering the ability to stand and walk independently can have numerous health benefits for people with SCI, and has been a priority in rehabilitation medicine. Robotic exoskeletons emerged a few years ago as a solution, allowing individuals with SCI to perform motor learning-based training with multiple repetitions of the locomotor task and minimal physical burden to therapists.

ABLE Exoskeleton is the rehabilitation tool for every clinic. A lightweight robotic exoskeleton for rehabilitation in the clinical setting that actively assists individuals with mobility impairments to stand up, walk, turn and sit down. The device results from years of collaboration with hundreds of clinicians and patients, integrating their feedback into the design to better address their needs.

“ABLE Exoskeleton’s technology is the fruit of hundreds of sessions with patients and therapists. Every single feature comes from attentively listening to what our users’ problems are and creatively solving them. From the mechanical design, to the electronic boards, the software, firmware or the control strategies, everything has been developed in-house by a remarkable group of engineering professionals”, said Alex Garcia, CTO of ABLE Human Motion.

ABLE Exoskeleton is an innovative and effective solution for clinics looking to offer their patients evidence-based therapy and the best practices for rehabilitation. The exoskeleton provides a physiological gait pattern that helps re-teach the brain and muscles how to walk again. Donning and doffing can be performed in less than 8 minutes, which maximises the therapy time for each patient.

Clinical trials with the device were conducted successfully in leading neurorehabilitation hospitals in Germany and Spain, proving the safety and performance of the exoskeleton for persons with spinal cord injury. Results showing improved clinical outcomes such as tolerance for gait training, body motor function, quality of life and well-being have been published in peer-reviewed scientific journals with high impact factors 1,2.

The certification entity has been BSI The Netherlands (2797), a leading Notified Body dedicated to providing rigorous regulatory and quality management reviews and product certifications for medical device manufacturers. For more than 100 years, BSI’s expertise has provided an assurance of safety and quality to manufacturers in over 180 countries.

Watch this video to learn more about the ABLE Exoskeleton: 

About ABLE Human Motion:

Founded in October 2018, ABLE Human Motion is a spin-off from Universitat Politècnica de Catalunya (UPC) that aims to create the most usable and accessible robotic exoskeletons in the world. Thus, driving widespread adoption of this technology that can change the lives of people with disability: enhancing their rehabilitation, mobility, quality of life and health.

 

1. M.A. Wright, F. Herzog, A. Mas-Vinyals, A. Carnicero-Carmona, J. Lobo-Prat, C. Hensel, S. Franz, N. Weidner, J. Vidal, E. Opisso & R. Rupp. Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations. Journal of NeuroEngineering and Rehabilitation, vol 20, 45 (2023).
2. A. Rodríguez-Fernández, J. Lobo-Prat, R. Tarragó, D. Chaverri, X. Iglesias, L. Guirao-Cano, J.M. Font-Llagunes. Comparing walking with knee-ankle-foot orthoses and a knee-powered exoskeleton after spinal cord injury: a randomized, crossover clinical trial. NATURE Scientific Reports, vol. 12, 19150 (2022).


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