Devices & Diagnostics

iPhone apps as medical devices (with FDA approval)?

… if you’re a radiologist, it seems some are: “We did a stroke trial … and compared performance of radiologists reading on the iPhone to the standard clinical reading work station and the performance was identical,” said Mitchell. “They performed just as well in this tough diagnostic task. “That’s a really good indicator that this […]

… if you’re a radiologist, it seems some are:


“We did a stroke trial … and compared performance of radiologists reading on the iPhone to the standard clinical reading work station and the performance was identical,” said Mitchell. “They performed just as well in this tough diagnostic task.

“That’s a really good indicator that this could be quite useful for diagnosing all sorts of things that aren’t as tough,” he added.

Mitchell said it’s currently being tested on the new iPad, which has a larger screen to view the images.

The application for iPhone and other mobile devices has been licensed as a medical device in Canada, said Philippe Laroche, a spokesman for Health Canada.

It’s still awaiting approval from the US Food and Drug Administration and CE Mark in Europe.

Now, the next blockbuster: the FDA-approval iPhone app!

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Westby G. Fisher, MD Website Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in […]

Westby G. Fisher, MD, FACC is a board certified internist, cardiologist, and cardiac electrophysiologist (doctor specializing in heart rhythm disorders) practicing at NorthShore University HealthSystem in Evanston, IL, USA and is a Clinical Associate Professor of Medicine at University of Chicago's Pritzker School of Medicine. He entered the blog-o-sphere in November, 2005. He writes regularly at Dr. Wes. DISCLAIMER: The opinions expressed in this blog are strictly the those of the author(s) and should not be construed as the opinion(s) or policy(ies) of NorthShore University HealthSystem, nor recommendations for your care or anyone else's. Please seek professional guidance instead.