Apple and FitBit not Medical Devices

Bill, a 31-year-old engineer from Ohio, has struggled with health anxiety for the most of his life. That’s why, in late 2020, he purchased a Fitbit Sense. He reasoned that being able to obtain an ECG reading when he sensed something odd, such as heartburn or an accelerated heartbeat, would convince him that he was healthy. Bill, on the other hand, became even more concerned after receiving inconclusive ECG results on the Fitbit Sense.

An inconclusive result does not imply a health problem; it simply means the gadget was unable to obtain an accurate reading. Fitbit explains on its website that this can happen if there is too much movement during the scan or if the wearer’s heart rate is too high or low. Bill, on the other hand, was unaware of this when, due to his worry around springtime last year, he was taking up to 20 ECGs per day.

The Fitbit Sense and comparable wearables, such as the Apple Watch, aren’t meant for medical diagnosis, as the manufacturers make clear. Smartwatches and fitness bands, on the other hand, can now track metrics like blood oxygen saturation and body fat estimates that used to necessitate a trip to the doctor or the use of a specialised instrument. Wearables are much more than activity trackers these days, but they’re not, and aren’t attempting to be, a replacement for medical care. So, what are they exactly?

That answer is starting to come together, based on interactions with medical experts, analysts, and officials at the firms behind some of these medicines. The industry has entered its awkward adolescent era, if you regard the early days of step counting and simple activity logging as the infancy of consumer health tracking.