Visage Imaging Receives FDA 510(k) Clearance for Visage Ease Pro Mobile Diagnostic App

The FDA has approved the 510(k) application for Visage Imaging’s Visage Ease Pro iOS app. (Note: A 510(k) submission is a premarket notification to the FDA demonstrating that the device is safe and effective for marketing, essentially granting authorization for legal commercial distribution.) In addition to mammograms, this mobile diagnostic app can interpret the vast majority of imaging data.

Visage Ease Pro is part of the Visage 7 imaging platform. It employs thin-client technology (compact, flexible computing devices that integrate high-performance CPUs and independently developed embedded operating systems to replace traditional PCs) along with server-side technology, leveraging cellular neural network algorithms to efficiently process massive volumes of research data. Additionally, the app can display medical digital images and communication information, record voice notes, or upload research-related photographs.

Visage Imaging also complies with FDA regulations for mobile apps, which stipulate that mobile devices may be used for diagnostic purposes only in the absence of a full diagnostic workstation, and prohibit mobile devices from processing mammography information. The company states that Visage Ease Pro is designed exclusively for integration with iPads and is not suitable for iPhones with smaller screens; however, user alerts can be displayed on the iPhone app.

(Translated by Zhang Nan)