The Importance of FDA-Approved Medical Image Viewers

Last month, we discussed the importance of having medical image viewers approved by the U.S. Food and Drug Administration (FDA) at SIIM 2015.

The benefits are numerous. Most importantly, with FDA approval, the users (referring physicians) are assured that the quality of the medical images that they are viewing are of a high quality that is appropriate for clinical decision making.

The FDA is very specific in what they consider to be a diagnostic device. It talks about a specific guideline about how a mobile device, or any device, is used for clinical decision making, and right now, the FDA is saying that a viewer must go through the FDA clearance process if it is going to be used for any sort of clinical decision making.

Radiologists’ customers, referring physicians, are looking at the patient medical images for clinical decision making on viewers, and more often these viewers are on mobile devices. Using a medical image viewer approved by the FDA means that there is compliance throughout the healthcare enterprise.

Carestream’s Vue Motion is FDA approved for clinical viewing on mobile devices, be it tablet, iPad, iPhone, or Android. The demo below shows Vue Motion in action and how it can bring an enterprise together around patient clinical data.

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