Technology | June 04, 2015

Visage Imaging Receives FDA Clearance for Visage Ease Pro

End-to-end enterprise imaging platform now supports mobile diagnostic use

Visage Imaging, Visage Ease Pro, FDA clearance

June 4, 2015 - Visage Imaging Inc. announced it received U.S. Food and Drug Administration (FDA) 510(k) clearance for the use of Visage Ease Pro for mobile diagnostic interpretation of all imaging modalities except mammography. Visage Ease Pro is a core component of the Visage 7 Enterprise Imaging Platform, enabling enterprise imaging with fast, thin-client, server-side processing technology.

Visage Ease Pro is a native iOS app with FDA clearance for mobile diagnostic interpretation that is a core component of an enterprise imaging platform designed for the diagnostic interpretation and clinical access of millions of imaging studies per year.

As a native iOS application, Visage Ease Pro has been optimized for simple, fast access to images and reports. To support diagnostic interpretation, the application requires the end user perform necessary calibration checks to ensure the display and environmental conditions are sufficient for diagnostic interpretation. Due to Visage 7's use of server-side processing, Visage Ease Pro can display even the largest multi-gigabyte-sized studies without performance degradation, even over cellular networks. Visage Ease Pro includes numerous image manipulation features, display of non-DICOM (and non-diagnostic) images, support for recording voice memos and the ability to upload photo attachments to studies on Visage 7.

The application also takes full advantage of the flexibility of iOS, offering customers the use of iOS push notifications, novel app-to-app integration via the use of the Visage 7 protocol handler, and for discriminating IT organizations, secure multi-factor authentication with integration to Active Directory.  

Consistent with general FDA principles for mobile apps, mobile devices should only be used for diagnosis in situations where no full diagnostic workstation is available (and not for mammography). Diagnostic interpretation using Visage Ease Pro should also only be performed on iPads due to the available screen real estate, with a user alert displayed when Visage Ease Pro is used on the iPhone.  

Visage Ease Pro is a free download from the Apple App Store, and requires Visage 7.1.6 (or later) for use.  It is also available for download via the Apple App Store for Canada, Australia and EU-countries (that accept English or German as languages of the IFU). Visage Ease Pro has been registered by Health Canada, TGA Australia and has received the CE Mark for mobile diagnostic use of imaging modalities other than mammography.

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