The FDA has granted 510(k) clearance to Visage Imaging’s Visage Ease Pro, a native iOS application that allows for mobile diagnostic interpretation of most modalities, excluding mammography.
Visage Ease Pro is a component of the Visage 7 Enterprise Imaging Platform that leverages thin-client, server-side processing technology. This server-side processing allows the app to display large studies without performance degradation even over a cellular network, according to the company. The app also can display non-DICOM images, record voice memos and upload photo attachments to studies.
Visage Imaging noted that, consistent with general FDA principles for mobile apps, mobile devices should only be used for diagnosis when no full diagnostic workstation is available, and not for mammography. The company added that interpretation with Visage Ease Pro should only be conducted on iPads and not the smaller-screened iPhone, and a user alert will be displayed with the app is used on the iPhone.