FDA emails reaffirm Apple may be developing a pair of cardiac monitoring devices

By , Nov 29, 2016

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Thanks to a recent Freedom of Information Act filing, we now know that Apple is still interested in developing a pair of FDA-regulated devices dedicated to cardiac monitoring.

This was revealed in a recent email exchange between officials at Apple and the United States Food and Drug Administration (FDA), which was obtained Tuesday by Mobihealthnews.

Economic Daily News reported on Apple’s alleged interest in the creation of two health-tracking hardware products back in August. According to that report, the devices—one of which described as a “killer” gadget—should release some time in 2017.

In one of the emails sent to Bakul Patel, FDA’s Associate Center Director for Digital Health, Robin Goldstein—who is Apple’s attorney in the Health division—discusses setting up an introductory meeting where “we will want to talk about two possible (and related) products in the cardiac space as well as the associated regulatory and quality systems and requirements.”

Three FDA executives were invited to the to meeting, originally titled “Apple introductory meeting—cardiac space” and later retitled to “Mobile medical apps”: Deputy Director of Science William Maisel, Cardiac Diagnostic Device Branch Chief Linda Ricci, and Director of Neurological and Physical Medicine Devices Carlos Peña.

The meeting was eventually cancelled, with Goldstein emailing Patel about the possibility of rescheduling a smaller meeting to discuss how Apple may engage with the FDA in a way that’s “non-regulatory”.

“So we can learn about your processes and thinking, and vice versa,” reads the email.

It’s unclear if a follow-up meeting actually took place, but sources inside the FDA told AppleInsider that “Apple is here all the time” discussing “a Parkinson’s project, and SaMD (software as a medical device) in general.”

An Apple-branded health monitoring device would need to be FDA-approved in order to be taken seriously. The FDA does take a light, almost hands-off approach to wearable devices such as the Apple Watch, but dedicated medical gadgets that include essential health-related functions need its official approval.

The FDA said last year that a wearable device must prove that it can treat specific diseases or conditions if it’s to be considered a regulated medical device rather than a general wellness gadget.

“We’ve gotten into the health arena and we started looking at wellness, that took us to pulling a string to thinking about research,” Apple’s boss Tim Cook said 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.”

Aside from the Apple Watch and the ever-improving Health app, Apple’s current health-related initiatives include HealthKit, ResearchKit and CareKit frameworks, in addition to partnerships with leading medical researchers, institutions and hospitals.

Source: Mobihealthnews via AppleInsider

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