Since its introduction in 2015, the Apple Watch has transformed from a fashion accessory to a highly capable health and fitness tracker. Recently, it received approval from regulators in the US. According to MyHealthyApple, the US Food and Drug Administration (FDA) has designated the Apple Watch’s atrial fibrillation (AFib) history feature as an MDDT – a Medical Device Development Tool. This means that the AFib readings on Apple Watch 4 and later models can be used to validate other medical devices in clinical trials, showcasing the accuracy of Apple’s wearables.
This endorsement from the FDA is significant as it is the first digital health technology to be approved for MDDT use. The AFib history feature on the Apple Watch has already received approval from the FDA, allowing Apple to market the wearables as having this capability. However, it is important to note that it is not a replacement for professional medical assessments.
The AFib monitoring feature on the Apple Watch is designed for individuals who have been diagnosed with the condition and are 22 years or older. This feature provides a non-invasive way to track the frequency of AFib signs. Over the years, the Apple Watch has continuously added new health and fitness features through hardware sensors and software updates, with watchOS 11 expected to bring more enhancements in June.
Although Apple has faced challenges, such as disputes over blood oxygen tracking patents that temporarily affected sales of certain Apple Watch models in the US, the FDA’s support adds credibility to the Apple Watch as a reliable health tracker. As rumors circulate about the upcoming Apple Watch 10, including display and battery life upgrades and design changes, it will be interesting to see how these developments impact the future of the device.