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Report: “more than 75” mobile medical apps have FDA clearance


According to Mobihealthnews, more than 75 510 (k) clearances have been granted by the FDA in the US that include a mention or description of a mobile software component.

The figure is based on the publication’s own research, as well as the agency’s database of summary decisions for 510 (k) clearances.

In the past, it was thought a relatively small number of apps had gained clearance.  The report shows actually the number was higher than previously thought.

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