“These emails show that Apple and the FDA have discussed the App Store review process, the 510(k) process, ResearchKit apps, diagnostic apps, working with the FDA in an ‘unregulated’ way and more. The FDA even invited Apple to participate in regular briefings designed to help guide an international effort to harmonize medical software regulation,” Comstock reports. “Though much of the sensitive information is redacted, the emails also point to three regulated medical devices that Apple is seriously pursuing: an app for diagnosing Parkinson’s disease and two separate but related cardiac devices. Finally, the emails also suggest that, after Apple received a good deal of press for its 2013 FDA meeting, the agency worked with Apple to keep future meetings under the radar.”
Comstock reports, “Apple’s plans for two cardiac devices and a Parkinson’s diagnostic app are a glimpse at what’s next for the company’s steady move into the medical world.”
Read more in the full article here.
MacDailyNews Take: </strongYes, it looks like Apple expects and is prepared to be crossing over the FDA’s regulatory line sooner than later.
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