FDA released a new guidance dated July 3, 2012 entitled ” Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data – Premarket Approval (PMA) and Premarket Notification [510(k)] Submissions. This guidance discusses types of Computer Aided Detection devices (CADe) and appropriate clinical data to include in 510(k)s and PMAs for these devices. This guidance is focused on radiology imaging devices that identify, mark, highlight, or in any other manner direct attention to portions of an image, or aspects of radiology data, that may reveal abnormalities.  View the document here CADe Clinical Trials guidance – 070312