The MyoPro electric arm, which uses motors to help multiple sclerosis patients move weakened arms and hands, has obtained a quality designation required for selling medical equipment in Europe.
Myomo‘s powered brace, which also helps people with spinal cord and nerve injuries, received what the European Union calls CE Mark certification.
The company rolled out the MyoPro in June 2017 as an update of a previous device. It allows a person with arm or hand paralysis to do things that would otherwise be impossible, such as carrying out daily household tasks and doing certain types of work.
Myomo used patented technology developed at the Massachusetts Institute of Technology to create MyoPro. It uses sensors on the arms to pick up a patient’s neurological signals. Then it activates motors to move arms and hands in the direction the patient wants.
There are three models available, to match different needs.
“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 a press 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.”
The CE Mark makes the device available in countries in the European Economic Area, which includes the European Union, Norway, Liechtenstein, and Iceland. The certification indicates that MyoPro complies with EU medical-equipment legislation.
“We are currently working with our partner Ottobock to plan our European launch beginning in Germany,” Gudonis said. “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.”
MyoPro is one of a number of MS assistive devices. Others include the SafeGait 360 Balance and Mobility Trainer, developed by Gorbel Medical; the Ekso wearable lower extremity exoskeleton, developed by Ekso Bionics; ReWalk 6.0, a motorized exoskeleton suit developed by ReWalk; and OkuStim, a device that addresses vision loss stemming from eye trauma, developed by Okuvision and others.