The Apple Watch AFib feature, which detects abnormal heartbeat patterns indicative of atrial fibrillation, has received a new tick of approval from the US Food and Drug Administration (FDA).
The FDA has now announced that the Apple Watch AFib feature has now qualified as a Medical Device Development Tool (MDDT). It says that this is the first ever digital health tech to qualify under the program.
This means researchers carrying out clinical studies into atrial fibrillation are now allowed to rely on Apple Watch AFib data as part of their findings. Specifically, an Apple Watch can now be used to determine the severity of AFib (known as the AFib burden) in order to determine whether treatment is needed, and then to measure the effectiveness of that treatment afterwards.
The MDDT qualification determines that the device creates “scientifically
plausible measurements.” Effectively, the FDA is stating that it is sufficiently
confident in the reliability of the feature to determine its results safe to use
in research studies.