macReports submitted a Freedom of Information Act (FOIA) request to the US Food and Drug Administration (FDA). We submitted our request in 2017. After more than three years, the FDA finally responded and made every document available. Our FOIA request asked the FDA to release everything about Apple.
The document includes a lot of sensitive, confidential and secret information but that information was redacted by the FDA.
The documents include some communications and also include a lot of information about scientific studies that Apple had done.
If you are interested in Apple, Apple and FDA relationships, and Apple’s health related products, you will find these documents very interesting.
There is information in these documents on the Irregular Rhythm Notification Feature for Apple Watch. This information includes identified risks of using this feature. These risks include: Failure to detect irregular heart rhythms, misinterpretation and/or over-reliance on device output leading to failure to seek treatment despite acute symptoms (e.g., fluttering sensation in the chest, lightheadedness, and irregular pulse), and discontinuing or modifying treatment for chronic heart condition. Also identified as risks are false negatives resulting in failure to detect irregular heart rhythms and delay of further evaluation or treatment, and false positives resulting in additional unnecessary medical procedures.
A study named the Apple Heart Study Sub-study looked into these risks by testing the positive predictive value (PPV) of the tachogram classification algorithm and confirmation cycle algorithm found that spot tachogram PPV for atrial fibrillation/atrial flutter (AF) and other arrhythmias is 98.4%, alert level PPV for AF and other arrhythmias is 98.2%.
As mentioned in these documents, Atrial Fibrillation (AF) is the most common serious cardiac arrhythmia and untreated AF is a leading cause of morbidity and mortality from stroke, heart failure and myocardial infarction. The documents also mention that many who have AF do not know they have it.
There are a lot of pages. In fact, there are more than 10,000 pages. There is a lot of information that you can find.
Again, these documents were made available due to macReports.com’s Freedom of Information Request.
The documents are available:
DEN180042
https://www.fda.gov/media/142588/download
DEN180044
https://www.fda.gov/media/142602/download
See also: How to Fix Apple Watch Battery Problems after watchOS 7 Update
Leave a Reply