Currently, there are about 15,000 medical apps that can be downloaded from Apple, mostly for iPhone and iPad. Apple’s App Store Medical has all kinds of medical applications to download that have been approved by Apple, but not necessarily the FDA.
The medical apps have been developed by CTO’s across the country, in a wild west, new frontier manner, without any regulations put forth by the FDA and the FDA is having difficulty keeping up with all of them. Some medical apps being developed are getting FDA pre-approval before launching them just in case there are regulations in the future. The approved apps will have a leg up on the ones that have not been FDA approved.
This July, the FDA issued some preliminary guidelines for software makers. It made it clear that it has no plans to regulate tablets and phones themselves as medical devices but it will look at the software. The FDA is expected to finalize their perameters by the end of this year.
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One medical app that has been FDA approved, was developed by CTO Mark Cain from MIM Software in 2008. The app allows doctors to view incredibly detailed scans of their patients with graphics and a touchscreen interface of a three-dimensional image of a human body, toggling between a CT scan and a PET scan. It was a painful process however, when in 2008, Apple accepted the app with enthusiasm, but a few months later, the U.S. Food and Drug Administration told MIM Software to remove their app from Apple’s store, saying it needed to be cleared for medical use.
The clearance took 2 years and $150,000.00. So if you are considering creating your own medical app, look into some of the current regulations being considered by the FDA.
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