Apple includes ECG in latest Watch
September 18, 2018
Apple has introduced a latest version of its Watch which supports cardiac health monitoring apps and wrist sensors. The US Food and Drug Administration has cleared the device for both uses. The FDA clearance allows the Apple Watch to be used as a personal cardiac data recorder for individual use. Data recorded by the Apple Watch can be presented to doctors. Apple partner company BioTelemetry has produced a cableless chest cardiac sensor, the ePatch, to complement the Apple Watch's new cardiac monitoring capabilities.
The new Apple Watch will also detect if its wearer falls over. If it detects a fall, the Watch prompts the wearer to alert emergency services. If it doesn't detect motion from the wearer after one minute, it will automatically alert emergency services.
Cardiac monitoring is more accurate when carried out with chest sensors. The BioTelemetry ePatch will allow the Apple Watch to wirelessly monitor the heart with greater accuracy than cardiac monitoring of the wrist.
Clinical cardiac monitoring is carried out typically using 12 leads, or more, arranged in a particular pattern across the chest. These allow for complex analysis such QRS and ST segment cardiac analysis. The Apple Watch is not a Class III medical device, and it is has received FDA clearance, not approval. The Apple Watch is considered to be a 'screening tool', not a clinical diagnostic tool.
However, Apple is keen to prove the utility of the Apple Watch for personal cardiac monitoring, and has initiated its first major healthcare study of its wearable technology. The Apple Heart Study will screen for heart rhythm abnormalities using the ePatch, the Apple Watch and the iPhone. Integration of clinical data, analysis and reporting will be carried out by BioTelemetry.
Doctors gave a mixed reaction to the news. A number of doctors tweeted that they believed the Watch would raise patient stress and anxiety levels, and prove counter-productive in managing cardiac health. They also stated that false positive reporting would rise, and visits to hospital emergency departments would rise.