Myomo Obtains CE Mark for MyoPro Powered Brace

Myomo Inc., a commercial stage medical robotics company, announced that it has obtained CE Mark approval for commercial sale of its next-generation MyoPro myoelectric arm orthosis across the European Economic Area (EEA). The CE Mark indicates MyoPro complies with the essential requirements of relevant EU legislation and has achieved quality system certification. 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 MyoPro powered brace allows individuals suffering from paralysis or stroke to perform routine daily activities,” said Paul R. Gudonis, Chairman and CEO of Myomo. “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.”
 
Gudonis continues, “We are currently working with our partner Ottobock to plan our European launch beginning in Germany. 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.”
 
Myomo launched its next-generation MyoPro orthosis in June 2017, extending the capabilities of the previous device. With the powered orthosis, a paralyzed individual can perform activities of daily living including feeding themselves, carrying objects and doing household tasks, and many are able to return to work. MyoPro is available in three models to match patient-specific needs.