Emails obtained by MobiHealthNews show Apple has been meeting with the FDA since July about two cardiac monitoring products. In the messages, Apple lawyer Robin Goldstein discussed “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.” The emails don’t contain any information about the products, but the company recently patented a wearable electrocardiographic health device that could have been part of the discussion. CEO Tim Cook has hinted at ambitious plans for Apple in the health field, admitting that the scope of his vision might require devices other than the Apple Watch. Goldstein ‘s exchanges with FDA Associate Center Director for Digital Health Bakul Patel show a concern on Apple’s part about keeping the discussion private, with Goldstein at one point asking to cancel a larger gathering in favor of “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.”
