ClaroNav Wins FDA 510(k) Clearance for NaviENT Surgical Navigation System
ClaroNav won FDA 510(k) clearance for its NaviENT surgical navigation system designed for endoscopic sinus and skull base surgery.
The image-guided surgical navigation system helps surgeons identify complex anatomic structures.
ClaroNav plans to launch the product in the U.S. in the coming months. The device had previously been granted CE mark approval for the European market and Health Canada approval in 2016.