Apple Watch's AFib feature, which detects abnormal heartbeat rhythms indicating atrial fibrillation, has received new approval from the FDA and US Drug Administration (FDA). Doctors have already noted that this healthcare feature saves lives.
Although the FDA had previously given approval for atrial fibrillation detection, it was a limited approval …
Apple Watch was previously ‘approved’ by the FDA ;
When the FDA first allowed Apple to enable atrial fibrillation detection on the Apple Watch, it was the least of the obstacles. Specifically, the 510(k) clearance granted by Apple effectively stated that the device was “substantially equivalent” to the device. to some existing device.
In other words, there were already optical pulse oximeters that worked just like the one on the Apple Watch, and they had already been shown to detect atrial fibrillation.
Because these earlier devices were already authorized, the new device effectively receives 510(k) clearance.
Now compliant with the MDDT program
The FDA announced that Apple Watch's AFib feature is now certified as a Medical Device Development Tool (MDDT).
It it is said to be the first digital health technology to qualify for this program.
The FDA announces the qualification of a new tool to evaluate stress assessment in atrial fibrillation (a type of arrhythmia or heart disorder) rhythm) in clinical training through the Medical Device Development Tools (MDDT) program.
Apple's Atrial Fibrillation History Feature is the first MDDT-certified digital health technology that provides a non-invasive way to verify severity scores atrial fibrillation (AF) in clinical trials.
What does this mean?
This means that researchers conducting clinical trials in atrial fibrillation are now allowed to rely on Apple Monitor atrial fibrillation data as part of their findings.
Specifically, the Apple Watch can now be used to determine the severity of atrial fibrillation (known as as the burden of atrial fibrillation) to determine whether treatment is necessary and then subsequently determine the effectiveness of that treatment.
The MDDT qualification specifies that the device produces “scientifically valid measurements.” In fact, the FDA says it has enough confidence in the reliability of this feature to determine its results are safe for use in scientific research.
I previously argued that the AFib story is the quiet beginning of a huge revolution at Apple Health.
- An Apple Watch user discovered a heart problem with atrial fibrillation using a new ECG app. “It may have saved you,” says doctor.
- Apple Watch skeptic discovers Fibritis days after ECG app reaches Europe.
- Apple Watch customer identifies heart condition caused by A-fib after calling the symptoms “holiday anxiety.”
- Apple Watch alerted a Seattle man that his A-fib had returned, potentially preventing a stroke.
- Reddit user says Apple Watch saved his life by helping him detect supraventricular tachycardia.
- Tim Cook shares story of user who discovered fibrillation and other health problems using Apple Watch
Via MyHealthyApple and Macrumors. Image: Apple
