To continue our product highlights within mobile health, we turn to Aycan's "Aycan Mobile" product which received clearance on September 12, 2012. A picture of its use on an iPad is shown on their website.

Based on the 510(k) summary (K122260), the application is intended to display medical images for diagnosis from CT and MRI modalities only (specifically excludes mammography images). It provides wireless and portable access to images, though not intended to replace traditional workstations. In fact, the app uses the Mobile MIM software (K103785) profiled earlier in the series as the predicate.

Does this clearance tell us much about the movement of mobile medical apps through the FDA? Well, just a little:

  • Imaging is the leading type of app to get through the FDA. Now, part of that is because there will be many apps that aren't considered medical devices, or may be considered Class I (typically not requiring 510(k) submission); however, in searching for news regarding apps and FDA clearance, I find imaging to be more prevalent in the search results. It's no shocker, of course, what with the great resolution of the "retina display" iPad and the equally stunning displays on its counterparts using the Android OS.
  • Speaking of Android, neither Mobile MIM nor Aycan have products cleared under the Android operating system. That tells me two things - Google Play has a much tougher challenge trying to catch up with the App Store's cleared medical application population; and, that if either company chooses to launch the app for use in the Android OS, there is another submission in their future.
  • Regulatory turnaround continues to be positive for these 510(k)s. The Aycan Mobile 510(k) was received by the FDA on July 27, 2012 and cleared on September 12, 2012. A grand-total of 47 days! Sure, that timeframe is atypical when compared against all submissions, but this is another example of a quick 510(k) clearance.

-RTK

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