Myomo Inc. has received CE mark approval for the commercial sale of its new MyoPro myoelectric arm orthosis, according to a company press release.
The approval signals that the new MyoPro, which the company launched in June 2017, complies with all essential European Union requirements and legislation, and has achieved quality system certification.
“The MyoPro powered brace allows individuals suffering from paralysis or stroke to perform routine daily activities,” Paul R. Gudonis, chairman and chief executive officer of Myomo, said in the release. “Gaining CE mark approval is an important milestone for our company and for the many people in Europe who will now be able to experience the benefits of MyoPro as they struggle with upper limb paralysis.”
According to the release, the MyoPro is “the only lightweight wearable device that can restore function in the paralyzed or weakened arms and hands of individuals who have suffered a stroke, spinal cord or nerve injury, or other neuromuscular disability.”
The newest generation of MyoPro orthoses expands on the capabilities of the previous device. The powered orthosis allows individuals with paralysis to perform activities, such as feeding themselves, carrying objects and completing household tasks, and has allowed many users to return to work, according to Myomo. The device is available in three models to match patients’ needs.
“We are currently working with our partner Ottobock to plan our European launch beginning in Germany,” Gudonis said in the release. “Myomo recently conducted sales and clinical training for Ottobock staff, which has begun evaluating patients for the MyoPro device. With revenue of over a billion Euros and operations in 50 countries, Ottobock is a global market leader in technical orthopedics and prosthetics.”