Since July 2016, Apple has been in discussions with the FDA about two FDA-regulated products in the cardiac monitoring space, MobiHealthNews has learned. The revelation comes from a collection of emails MobiHealthNews obtained via a Freedom of Information Act request to the FDA.



On July 14, 2016, Robin Goldstein, at the time Principal Counsel for Apple, sent an email to FDA Associate Center Director for Digital Health Bakul Patel. According to her LinkedIn, Goldstein’s title changed shortly thereafter to “Special Projects -- Health.”



“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 invited three other FDA officials to the introductory meeting: William Maisel, deputy director of science and chief scientist; Linda J Ricci, branch chief for cardiac diagnostic devices at the FDA; and Carlos Peña, director of the division of neurological and physical medicine devices. Goldstein also wanted Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, to attend but Goldstein left him out of the email citing a “concern”, the exact nature of which was redacted by the FDA.



Patel sent another invitation a few days later, changed the meeting title from “Apple introductory meeting - cardiac space” to “Mobile medical apps”. This time he included Shuren in the invitation, as well as Bram Zuckerman, director of the FDA’s Division of Cardiovascular Devices. The change seems to have been related to a need for discretion in light of Shuren’s calendar being public.



“Hi Bakul. Got approval from Jeff Williams to have Jeff Shuren join us next week if we’re able to title the meeting Mobile Medical Applications (which I think you said would be okay),” Goldstein wrote to Patel. “Just wanted to confirm.”



Patel replied: “So the meeting I sent yesterday has the title Mobile medical app discussion -- that should work.”



Although the attendee roster of that proposed meeting is interesting, in fact it never seems to have taken place. Even after the reschedule, Goldstein sent Patel another email saying, “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’ so we can learn about your processes and thinking, and vice versa.”



The emails don’t contain many details about the two devices Goldstein alluded to, but a wearable ECG device of some kind is one possibility. The form factor could be a combination of the Apple Watch and a modular strap for the Watch. Apple CEO Tim Cook hinted that a regulated medical device from Apple would be something along those lines in an interview with the Telegraph last fall.



“We don’t want to put the Watch through the Food and Drug Administration (FDA) process,” he said at the time. “I wouldn’t mind putting something adjacent to the watch through it, but not the watch, because it would hold us back from innovating too much, the cycles are too long. But you can begin to envision other things that might be adjacent to it -- maybe an app, maybe something else.”



According to the Telegraph, Cook was bullish on health prospects for the Apple Watch after hearing the story of a teenager whose life was saved by his Apple Watch data. We also know that Apple is thinking about ECG technology at least on some level. In August, Patently Apple spotted an Apple patent for a wearable ECG device. The device could read ECG from the wrist and fingertip once the user calibrated it by taking readings on various parts of their body. Obviously many Apple patents never see the light of day, but it does suggest some level of investment in the space.



It’s worth noting also that at least one startup believes the Apple Watch’s off-the-shelf hardware is already capable of delivering actionable clinical information, and has put that theory to the test in partnership. Cardiogram has been working with UCSF since March to collect user data in a study called mRhythm and use it to develop an app for detecting atrial fibrillation based on on Apple Watch data.



"If you own an Apple Watch, its native software already measures your heart rate once every five minutes, or continuously if you're working out," Cardiogram CEO Brandon Ballinger said in a recent statement. "That data does get stored in your Health app, but it's just raw data, and not easily understandable. What Cardiogram does is organize this info in graphs both real-time short-term graphs, like your heart rate over the course of a stressful meeting, and long-term trend graphs, like resting heart rate over time. Plus, we give you full access to the underlying metrics."



Of course, there are a few iPhone connected third party ECG devices already in existence, the best known is made by AliveCor (which is also working on Kardia Band, an ECG built into a strap for the Apple Watch). Asked about a hypothetical device from Apple, AliveCor inventor Dr. Dave Albert told MobiHealthNews he was skeptical, but that it would actually be great for the incumbent players.



“Nothing would be better for AliveCor than Apple introducing an ECG device but I am very skeptical,” he told MobiHealthNews in an email. “The market is small in Apple terms. Most iPhone customers don't need an ECG. However, were they to introduce something, I suspect AliveCor would be acquired in a nanosecond. Alphabet, Microsoft, Fitbit, Medtronic, GE, Philips, Samsung, Huawei, Xiaomi, etc. would need a solution fast and getting into the highly regulated medical field would not be fast for any of the nonmedical companies and the medical companies take years to develop products.”



On the other hand, Vital Connect CEO Nersi Nazari has a different opinion. His company makes a smartphone-connected, peel-and-stick sensor for home and hospital monitoring that can read ECG as well as other vital signs. In an interview with MobiHealthNews, he noted that if Apple were to get into patient monitoring on the medical side, it wouldn’t just be competing with small startups but with large players like Philips and GE.



“If any major company gets into it, it probably would have some effect,” he said. “But as you know there are already major medical companies that are in the market such as GE [and] Philips. There’s no shortage of large companies with very good technology in the medical side. It’s not like Apple is getting into a small market that didn’t have big players to begin with.”

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