The Apple Watch Series 6 added a blood oxygen sensor to measure the level of oxygen in your blood. Unlike the ECG sensor introduced with the Apple Watch Series 4, the pulse o I meter is marketed as a “wellness” feature, not a medical feature (via The Verge).
Apple Watch Series 6 Pulse Oximeter
The Apple Watch ECG function had to go through a long process with the Food and Drug Administration. Because of FDA approval, Apple could legally call the Series 4 a medical device.
The distinction between a feature used for wellness and one used for medical monitoring is important — one has been cleared by experts, and the other hasn’t. But those differences often aren’t clear to people buying a product like an Apple Watch, particularly when the marketing blurs the line — as Apple did when it directly compared the heart monitoring features on the watch to the new pulse oximeter.
As a Class 2 medical device, companies who want to sell a pulse oximeter has to submit documentation saying it works just as well as similar products on the market. But if the company says it’s for “wellness” which is a more nebulous term, that’s different. Apple can’t say Series 6 can diagnose or treat medical conditions.