pdf Pro Medicus Receives FDA Clearance for Visage Ease Pro – Acrobat pdf 105k

19 May 2015

Leading imaging IT provider, Pro Medicus Limited [ASX: PME], today announced its wholly-owned US subsidiary Visage Imaging Inc has received US Food and Drug Administration (FDA) 510 (k) clearance for its Visage Ease Pro mobile app technology.

Visage Ease Pro has been certified for diagnostic interpretation of all imaging modalities apart from mammography which requires higher screen resolution than current mobile devices can support.

“With Visage Ease, our current mobile app, we lead the pack in terms of speed and functionality for review access of images. Our new Pro version has raised the bar even further. Incorporating the ability to quickly check the calibration of the screen of an iOS device means that radiologists and allied physicians that require full diagnostic capability on the go can now have it on their mobile device. This enables them to securely interpret images no matter how large they are anywhere using Visage technology.”

Visage Ease Pro includes numerous image manipulation features, display of non-DICOM (and non-diagnostic) images such as photos, support for recording voice memos, and the ability to upload photo attachments to studies on Visage 7.

Dr Hupert said: “FDA clearance represented the culmination of 12 months of regulatory negotiations. We join only a handful of other mobile applications that have received FDA approval but we believe ours is the only FDA approved mobile solution that is an integral part of a total enterprise imaging platform.”

Dr Hupert also said that the technology has been approved for use in Australia by the Therapeutic Goods Administration, as well as in Canada and Europe. “This approval worldwide represents further validation of the extent and functionality of our product,” he said.

Visage Ease Pro will be available as a free download from the Australian Apple App store in June.