Daxor to resubmit 510(k) application for blood volume analyzer platform

Daxor announces a strategic update to its regulatory approach for its novel diagnostic blood volume analyzer platform. Following productive discussions with the U.S. FDA, the company has decided to withdraw its current dual 510(k)/CLIA-waiver application and resubmit a focused 510(k) application. This decision comes after considerable progress in addressing key regulatory considerations and aims to expedite the approval process, potentially bringing this innovative technology to patients sooner. Daxor plans to pursue a separate CLIA-waiver application subsequently, allowing for a more targeted approach to each regulatory pathway. The company expects to submit the new 510(k) application in the coming quarter and will provide updates on its progress in the regulatory process, as appropriate.