PeekMed (Braga, Portugal) recently announced that it has received ISO 13485 certification and CE Mark for its flagship 3D pre-operative system for orthopedic surgeons.
The new CE Mark allows PeekMed to sell its system in Europe. It is currently working on obtaining FDA 510(k) approval to market in the U.S.
PeekMed helps orthopedic surgeons plan their surgeries and it used by more than 700 people around the world.
“CE mark approval and ISO 13485 certification are an important achievement for PeekMed. This milestone validates the dedication of the entire team that works daily to deliver innovative products of the highest quality,” João Pedro Ribeiro, CEO of PeekMed, said. “This is to fulfill our mission and vision for the market, to provide surgeons with tools that assist them with more rigorous and objective planning, making the surgery more predictable, effective and safe for the patient.”
The company also recently updated its system to bring a new design and new features to its product. PeekMed v2.0 can be combined with the first 3D mobile app for pre-operative planning in orthopedics to make it easier, faster and safer for orthopedic surgeons to plan procedures.