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Recent Apple emails with FDA reveal interest with cardiac monitoring hardware, Parkinson's support

A recent Freedom of Information Act filing has revealed that Apple's ambitions still extend into cardiac monitoring technologies, with meetings scheduled between the Apple Watch maker and the U.S. Food and Drug Administration over the summer of 2016 regarding a pair of devices.




One of the emailsobtained by Mobihealthnews is from Apple ex-general counsel and current attorney in the company's health division Robin Goldstein, and was sent to FDA Associate Center Director for Digital Health Bakul Patel.
"Apple is here all the time" - FDA staffer
"As we discussed, I think this will be an introductory meeting where we will want to talk about two possible (and related) products in the cardiac space," wrote Goldstein. "As well as the associated regulatory and quality systems and requirements."

Also invited to the "Apple introductory meeting - cardiac space" meeting were three FDA executives. Deputy Director of Science William Maisel, Cardiac Diagnostic Device Branch Chief Linda Ricci, and Director of Neurological and Physical Medicine Devices Carlos Peña, were all invited to attend the introductory meeting.

A fourth executive was invited to the meeting —FDA Director for the Center for Devices and Radiological Health Dr. Jeffrey Shuren was mentioned as well, but not immediately included in the invitation because of an Apple "concern" which was redacted by the FDA prior to release, presumably because Shuren's calendar is public.

Later in the email chain, the meeting was retitled to "Mobile medical apps" and Shuren was confirmed to attend. Ultimately, the meeting was cancelled.

"We agree it makes sense to cancel the planned Monday meeting and reschedule a smaller meeting to discuss how Apple may engage with the FDA in a way that's 'non-regulatory'," Goldstein emailed Patel. "So we can learn about your processes and thinking, and vice versa."

While AppleInsider was not able to confirm that a follow-up meeting took place on this particular topic in even an obfuscated fashion, sources inside the FDA tell us that "Apple is here all the time" discussing "a Parkinson's project, and SaMD (software as a medical device) in general."

Apple's ambitions with health monitoring aren't a secret. The sensors on the Apple Watch interface with the Health app on the iPhone to track a user's fitness efforts, and Apple's ResearchKit can utilize this data with user permission as well.

"We've gotten into the health arena and we started looking at wellness, that took us to pulling a string to thinking about research," said Apple CEO Tim Cook in an interview in August. "Pulling that string a little further took us to some patient-care stuff, and that pulled a string that's taking us into some other stuff."