Apple Heart Study not used to gain FDA clearance for Apple Watch Series 4 ECG
The Apple Heart Study, conducted in partnership with Stanford Medicine, collected heart rate data from more than 400,000 Apple Watch users in its attempt to determine whether wearable devices can effectively detect irregular heart rhythms. Contrary to previous reports, however, the results were not used to gain clearance from the U.S. Food and Drug Administration for Apple Watch Series 4's ECG feature.
The ECG app on Apple Watch Series 4.
Stanford revealed the scope of the Apple Heart Study in an announcement Thursday, saying the clinical trial was the largest screening study on atrial fibrillation ever conducted. A paper detailing the study and its design was published in the American Heart Journal today.
Apple closed enrollment in August, some eight months after it launched the program in 2017. Participants began receiving word that the study was complete in September, though Stanford says data collection will be completed early next year, in line with previous statements from Apple.
Following the closure to enrollment, Apple quietly submitted a de novo request for FDA clearance to two Apple Watch apps that would feature prominently in Apple Watch Series 4. The first app handles interpretation of and display of electrocardiogram readings from the wearable's new ECG system, while a second uses optical sensors to identify irregular heart rhythms.
The FDA issued regulatory Class II clearances -- over-the-counter access -- for both.
Previous reports claimed Apple leveraged the Heart Study in both de novo requests, but Stanford says the trial was used only in respect to atrial fibrillation notifications.
The clarification makes sense, as the Heart Study related to atrial fibrillation, not ECG systems or data collection. During the months-long trial, a specialized app collected pulse rate data from Apple Watch Series 1, 2 and 3 hardware. In some cases, the app was able to detect and notify users of irregular pulse rate episodes.
The study, according to Stanford, sought to determine how many patients who received irregular pulse notifications were found to have atrial fibrillation, and how many went on to get medical attention. Calculating the accuracy of the system against simultaneous ECG recordings was a tertiary goal of the trial.
Though it did not factor into regulatory approval of Apple's ECG solution as previously thought, the Heart Study can be considered an important first step toward providing consumers with easily accessible medical hardware.
"We now have access to high-quality sensors that can measure and detect changes in our bodies in entirely new and insightful ways without even needing to go to the doctor, but we need to rigorously evaluate them," said Mintu Turakhia, MD, associate professor of cardiovascular medicine at Stanford. "There's never really been a study like this done before."
Apple is expected to activate the ECG feature in Apple Watch Series 4 later this year.
The ECG app on Apple Watch Series 4.
Stanford revealed the scope of the Apple Heart Study in an announcement Thursday, saying the clinical trial was the largest screening study on atrial fibrillation ever conducted. A paper detailing the study and its design was published in the American Heart Journal today.
Apple closed enrollment in August, some eight months after it launched the program in 2017. Participants began receiving word that the study was complete in September, though Stanford says data collection will be completed early next year, in line with previous statements from Apple.
Following the closure to enrollment, Apple quietly submitted a de novo request for FDA clearance to two Apple Watch apps that would feature prominently in Apple Watch Series 4. The first app handles interpretation of and display of electrocardiogram readings from the wearable's new ECG system, while a second uses optical sensors to identify irregular heart rhythms.
The FDA issued regulatory Class II clearances -- over-the-counter access -- for both.
Previous reports claimed Apple leveraged the Heart Study in both de novo requests, but Stanford says the trial was used only in respect to atrial fibrillation notifications.
The clarification makes sense, as the Heart Study related to atrial fibrillation, not ECG systems or data collection. During the months-long trial, a specialized app collected pulse rate data from Apple Watch Series 1, 2 and 3 hardware. In some cases, the app was able to detect and notify users of irregular pulse rate episodes.
The study, according to Stanford, sought to determine how many patients who received irregular pulse notifications were found to have atrial fibrillation, and how many went on to get medical attention. Calculating the accuracy of the system against simultaneous ECG recordings was a tertiary goal of the trial.
Though it did not factor into regulatory approval of Apple's ECG solution as previously thought, the Heart Study can be considered an important first step toward providing consumers with easily accessible medical hardware.
"We now have access to high-quality sensors that can measure and detect changes in our bodies in entirely new and insightful ways without even needing to go to the doctor, but we need to rigorously evaluate them," said Mintu Turakhia, MD, associate professor of cardiovascular medicine at Stanford. "There's never really been a study like this done before."
Apple is expected to activate the ECG feature in Apple Watch Series 4 later this year.
Comments
It could have been seen as Apple influencing the decision to clear it.
Also about those OTC FDA approvals. While receiving FDA approval is a sign of the ECG feature having a high degree of accuracy, certain consumer medical devices can be approved even if there is a chance they could provide imperfect information. The FDA already approves a range of devices which have varying degrees of accuracy, as they suit different use cases. A single-lead ECG Apple Watch has significant benefits over the risks.
A good parallel to think about is the home pregnancy test kit. Yes it can provide a false positive, but it's allowable because the risks associated with false positives are low and it keeps medical costs down while unclogging the system for more urgent care. Those with a positive result can seek a medical professional for higher certainty in a single appointment, rather than an appointment every time there are symptoms.
The same applies with the ECG - it's going to help reduce the workload on medical professionals, especially as irregular heart behaviours can't be reproduced on command in the window of a doctor's appointment and that other symptoms(such as muscular spasms or digestion) can feel like issues with the heart.
Physicians, and to a much lesser extent, researchers, are not always the best at determining anything, because they don't have access to all the data (deliberately so), and their perspective is often skewed by their own skill level, or lack of it, and attention to clinical data recording and patient followup requirements.
Unfavorable trials may indeed not be submitted ("published" is the wrong word to use), but they are a permanent part of the Design History File, and/or the Device History Record, depending on the stage of development. Any attempt to bury things like that will buy you jail time and significant fines when discovered by FDA and it doesn't match the data you submitted.
FDA focuses IND and IDE reviews on safety and ensuring that the study will provide useful information once completed. NDA and PMA review is on the data itself and on data analyses, NOT on expert reports.
Since (apparently) you've never had to try to reason with FDA, or be subject to their repeated unannounced inspections, or re-conduct a clinical, it's hard to say I'm spreading propaganda for anybody. This industry can take years off of your life.
It's simply a fact that physicians don't have all the data in a clinical because that's the way trials are constructed, the research data and clinical data are part of the permanent records, and you will go to jail, or at least lose your worldly possessions, if you fail to play by the rules. Yes, many try to skate (I have issues with several big corps in the industry), and some cheat for a while, but sooner or later you get caught and maybe you're lucky if FDA just decides they're taking over several prime office spaces in your company for the next five years while they look at every document in the building. I've seen that exact thing happen up close. 483s are just the beginning of the misery.
You know they carry badges, right, and the US Marshalls are number one on their speed dial? This shit is real, and they'll lock your doors.