Apple Plans Two FDA-Regulated Cardiac Devices, Emails Hint

Apple Plans Two FDA-Regulated Cardiac Devices, Emails Hint

Apple has been planning two new FDA-regulated devices intended for cardiac monitoring, a series of emails sourced by MobiHealthNews through a Freedom of Information Act request has revealed.

The health news site sent this request to the US Food and Drug Administration. It was discovered that, on July 14, 2016, Robert Goldstein, then Principal Counsel for Apple, emailed FDA Associate Center Director for Digital Health, Bakul Patel.

“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, as well as the associated regulatory and quality systems and requirements,” Goldstein wrote.

Patel then invited three FDA executives to this meeting – which, in the email chain, was titled “Apple introductory meeting – cardiac space” before being retitled “Mobile medical apps”. Still, it was seemingly cancelled, with Goldstein seeking an alternative meeting “to discuss how Apple may engage with the FDA in a way that’s ‘non-regulatory'”.

While these emails say little about the actual devices, MobiHealthNews notes that “a wearable ECG device of some kind” in the form of “a modular strap for the Apple Watch” is possible. Last fall, Apple CEO Tim Cook hinted to The Telegraph that Apple could put such a device to RDA approval, rather than the Apple Watch itself, as that strategy would overly hinder Apple’s innovation drive.

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