While there’s no doubt that Apple’s ECG feature on the new Apple Watch Series 4 is breaking new ground, experts note that it’s nowhere near providing the kind of detail that professional ECG measuring equipment is capable of. Speaking with Quartz, Dr. Andrew Moore, an emergency department physician at the Oregon Health and Science University, explained that in an actual health care facility, a patient would have 12 different leads placed at different points on their body, whereas the Apple Watch, by the company’s own admission, is the equivalent of a single lead on the user’s wrist, adding that, “The tech that Apple is working with is very rudimentary compared to what we’d do for someone in a hospital or health care setting.” While the watch is capable of using the ECG monitor to detect Atrial Fibrillation (AFib) — a serious medical condition that affects between 2.7 and 6.1 million people in the U.S. — it should be considered merely an indication that the user should seek professional medical advice, and is not nearly as good as an actual medical diagnosis. “The ECG thing is a little bit overhyped in terms of what it will really provide,” Moore added.
The report goes on to note that the Apple Watch Series 4 meets the minimum legal requirements for the FDA to clear it for these purposes, however this “cleared” status is a minimum standard given to medical devices that are considered to be “of low to moderate risk to the general public,” and involve much less rigorous testing than something like a pacemaker would go through. Apple received its two FDA clearances through what’s known as a “de novo” pathway, which means that company was only required to show data providing that the Apple Watch Series 4 worked as advertised, and was safe. For the ECG clearance, a study conducted by Apple and Stanford University was submitted to the FDA, but represented a relatively small sample group of only 588 individuals, half of whom had AFib. The report notes that the app was 98 percent accurate as identifying the patients with AFib and 99 percent accurate identifying the patients with healthy heart rates. Most interestingly, however, is that cardiologists were only able to decipher 90 percent of the total readings made by the technology. The irregular heart-rate notification clearance used a subset of the data from the Apple Heart Study, which included 226 participants who had already been identified as having AFib, with the Apple Watch sensor identifying AFib in about 40 percent of the cases.
The report also highlights the FDA’s approval letters for the technology, where the agency notified Apple of the risks of inaccurate readings, requiring that Apple clearly label those risks and warn users about situations where the Apple Watch technology may not work, and of course adding the typical cautions that the Apple Watch is not a substitute for actual medical care, and patients should always consult an actual physician before making any medical decisions. [via iPhone in Canada]