Videos

CE Mark Granted to CyMedica Orthopedics for Bracing Technology (includes video)

Device was designed for patients suffering from quadriceps muscle atrophy after surgery.

Scottsdale, Ariz.-based CyMedica Orthopedics Inc. received a CE mark for its QB1 Muscle Activation System. The product received its U.S. Food and Drug Administration 510(k) clearance in April.

According to the firm’s leadership, CE mark opens new international markets to the QB1 to benefit patients suffering from quadriceps muscle atrophy (or quad atrophy)—a weakening of the major leg muscles after anterior cruciate ligament and total knee replacement surgery. Experts claim that quad atrophy can significantly slow healing and affect a patient’s activities, leaving them prone to delayed rehabilitation and further injury.

“Securing the CE mark for the QB1 System marks an important milestone for our company, greatly expanding our market opportunity to patients in Europe and paving the way for a global sales and distribution network. We are excited to have the clearance to deliver our revolutionary technology to millions of patients outside of the United States,” said Rob Morocco, president and CEO of CyMedica Orthopedics. “Having recently launched domestically, we will continue to dedicate ourselves to expanding our market penetration within the US as we evaluate the timing and structure of our plans to commercialize the QB1 internationally.”

CyMedica Orthopedics brought together leading orthopedic surgeons, physical therapists and engineering experts for input in developing the QB1. The system incorporates patented and intelligent technology with a postoperative knee brace to bring rehabilitation therapy into a patient’s home that, according to company officials, enables all knee patients to potentially improve their quad strength faster and more comfortably than with other methods.

CyMedica Orthopedics is privately held.

Check out a demonstration of the device.


Keep Up With Our Content. Subscribe To Orthopedic Design & Technology Newsletters