Axinesis announced that its innovative medical interactive robotic device, REAPlan, dedicated to the rehabilitation of impaired upper limbs of stroke patients and cerebral palsy children, has received CE mark approval according to Directive 93/42/EEC on medical devices.
Axinesis’s REAplan, is an ergonomic, interactive and auto-adaptive device, combining robotics and therapeutic gaming to improve the rehabilitation of impaired upper limbs. REAplan differentiates from existing solutions by offering real time automated personalised assistance of arm movements. REAplan has been evaluated on more than 300 patients and results demonstrated improved recovery of impaired upper limbs in clinical practice.
CE marking indicates a full compliance with European Union regulations governing medical devices.
The company is poised to begin immediate sales and distribution in select EU countries:
“This is an important milestone in our mission to provide state-of-the-art technologies dedicated to the rehabilitation of brain-injured patients” said Eric Hanesse, CEO of Axinesis. “The continual requests from customers for products enhancing patients’ rehabilitation, and the feedbacks of users on this project have been exceptional. We are very pleased to offer an innovative high-end technology, for a very affordable investment, to the European rehabilitation community and expand the clinical options available to all.
Robotics, integrated in rehabilitation programs, enable stroke patients to accomplish significant numbers of moves with their arms, fostering a natural reconstruction process of the brain, called neuroplasticity. Based on our current data and results, REAplan can help over 5 million people worldwide, left permanently disabled after a stroke event (*), as well as children affected by the most common childhood disability, cerebral palsy”.