Visage Imaging Receives FDA Clearance for Visage Ease Pro

May 20, 2015 - Visage Imaging Inc. received FDA 510(k) clearance for the use of Visage Ease ProTM for mobile diagnostic interpretation of all imaging modalities except mammography. Visage Ease Pro is a core component of the Visage 7 Enterprise Imaging Platform.

This supports enterprise imaging with reportedly fast, thin-client, server-side processing technology scaled to support the imaging needs of the world’s largest healthcare institutions.

Visage Ease Pro is the first and only 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.

“Clinicians and radiologists can now securely interpret any image (other than mammography), nearly anywhere, using Visage Ease Pro. Since the earliest days of medical imaging, that has been the rallying cry for our industry,“ said Brad Levin, General Manager, North America and Global Head of Marketing.

Malte Westerhoff, PhD, Visage Imaging’s Co-Founder and Chief Technology Officer added, “The platform responsible for the power of Visage Ease Pro is Visage 7, with its smart server-side processing capabilities. No separate servers dedicated for mobile use are required as it’s all integrated into one universal viewing platform.” Dr. Westerhoff continued, “Tens of millions of annual studies can be processed by a single Visage 7 system for high-volume diagnostic interpretation by hundreds of radiologists, clinical review by tens of thousands of clinicians, and now with Visage Ease Pro, near anywhere mobile diagnostic interpretation.”

As a native iOS application, Visage Ease Pro has been optimized for simple, fast access to images and reports. To support diagnostic interpretation, Visage Ease Pro 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. Visage Ease Pro 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. This robust level of native app integration and overall usability is not found when competing browser-based image viewers are used on mobile devices.

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.

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