SmartCella Holding AB (SmartCella) today announces the FDA has approved the Smartwise Extroducer catheter giving it clearance to approach the US market. This is SmartCella’s first US regulatory approval, and it allows the Extroducer to be used in organs such as the kidney, pancreas and liver.
Johan Ruglfelt, acting CEO states “The FDA-clearance is an important milestone for us. It means we have passed the requirements on safety and performance set by the most important regulatory agency in the world. It is a great stamp of quality, and it will allow us to accelerate on all fronts, in business discussions as well as in research and clinical collaborations with academia and life science companies. It will also facilitate recruitment of talent needed further which is crucial for us when building SmartCella for the future.”