The Medical Device Development Tools (MDDT) program of the United States Food and Drug Administration (FDA) has approved the Apple Watch’s atrial fibrillation (AFib) history feature, which keeps track of and notifies the wearer of relevant heart events. This is the first of its kind for a “digital health technology.” According to 9to5Mac, this means that the Apple Watch can now be used in clinical research that requires approximations of the wearer’s atrial fibrillation duration while wearing the device.
According to the FDA statement, it can be used as a non-invasive method of gathering data both before and after treatment. The FDA stated that the device was designed to serve as a biomarker test to assess estimates of the burden of AFib as a secondary effectiveness endpoint in studies aimed at assessing the efficacy and safety of cardiac ablation devices for treatment.
Apple has long marketed its watch as a wearer’s lifesaver It has been said that certain features, like fall and auto accident detection, have helped save lives. In its marketing, Apple frequently uses user testimonials from Apple Watch wearers who indicated that they consulted their doctors after getting heart-related notifications on their wrists, which may have saved their lives. But on the other hand, anxiety through further that information might also be harmful.
Starting with the Series 4 in 2018, the FDA had previously approved two Apple Watch functions to be sold directly to consumers as wearables with an electrocardiogram that could detect abnormal heartbeats. Additionally, it clearly stated that the apps are “not intended to replace traditional methods of diagnosis or treatment” and that you should still see a licensed physician if you feel unwell or have any questions. According to one study, the treatments for certain disorders may not be appropriate for the average Apple Watch wearer, and the watch itself cannot diagnose conditions.
Olagoke Ajibola is a creative writer and content producer with an eye for details and excellence. He has a demonstrated history of telling stories for TV, Film and Online. Aside from being fascinated by the power of imagination, his other interest are travel, sport, reading and meeting people.
To provide the best experiences, we use technologies like cookies to store and/or access device information. Consenting to these technologies will allow us to process data such as browsing behaviour or unique IDs on this site. Not consenting or withdrawing consent, may adversely affect certain features and functions.
Functional
Always active
The technical storage or access is strictly necessary for the legitimate purpose of enabling the use of a specific service explicitly requested by the subscriber or user, or for the sole purpose of carrying out the transmission of a communication over an electronic communications network.
Preferences
The technical storage or access is necessary for the legitimate purpose of storing preferences that are not requested by the subscriber or user.
Statistics
The technical storage or access that is used exclusively for statistical purposes.The technical storage or access that is used exclusively for anonymous statistical purposes. Without a subpoena, voluntary compliance on the part of your Internet Service Provider, or additional records from a third party, information stored or retrieved for this purpose alone cannot usually be used to identify you.
Marketing
The technical storage or access is required to create user profiles to send advertising, or to track the user on a website or across several websites for similar marketing purposes.
