FDA OKs new Visage app

Advanced visualization and PACS firm Visage Imaging has received U.S. Food and Drug Administration (FDA) clearance for Visage Ease Pro for mobile diagnostic interpretation of all imaging modalities except mammography.

Visage Ease Pro is a native iOS app and core component of the Visage 7 enterprise imaging platform, Visage said.

Visage Ease Pro requires end users to perform calibration checks to ensure that the display and environmental conditions are sufficient for diagnostic interpretation. Due to Visage 7's server-side processing, Visage Ease Pro can display large multigigabyte-sized studies without performance degradation, even over cellular networks, according to the firm.

The app includes image manipulation features, display of non-DICOM (and nondiagnostic) images, support for recording voice memos, and the ability to upload photo attachments to studies on Visage 7. Visage Ease Pro also offers iOS push notifications, novel app-to-app integration via the use of the Visage 7 protocol handler, and secure multifactor authentication with integration to Active Directory.

Diagnostic interpretation using Visage Ease Pro should 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, the firm added.

The app has been registered by Health Canada and Australia's Therapeutic Goods Administration (TGA), and it has received the CE Mark for mobile diagnostic use of imaging modalities other than mammography.

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