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These devices are moving beyond the wellness sector and into medical care. From earbuds that work as hearing aids to socks that monitor babies’ vital signs, wearable health gadgets have come a long way since the early fitness trackers that encouraged people to get 10,000 steps a day. Now, powered by miniature sensors and artificial intelligence (AI) that gives users highly detailed data on their health, wearables like the Oura ring and Apple’s smartwatch are straddling the line between personal wellness tools and actual medical devices – though there’s still progress to be made before hype becomes reality.
“People are learning that going to a doctor to get medical information is both inadequate and inefficient because you get to see your doctor for 15 minutes and he or she asks you a few questions and gives you some advice ...
and then you’re off,” Oura CEO Tom Hale told Euronews Health at the 2024 Web Summit in Lisbon. The Oura ring’s sensors take continuous measurements from people’s fingers, which have strong pulse signals, to track blood oxygen levels, heart rate, and body temperature, and then give them personalised insights about their stress, sleep quality, activity levels, and more. For those who can afford it – Oura’s price starts at €399 – these kinds of wearables could become “the doctor in your pocket,” Hale said.
The wellness sector has exploded in recent years, partly because it’s not subject to the same strict regulations as medical devices and treatments. But Oura, Apple and a handful of other companies are moving into the regulated health sector in a bid to make their products more widely available and differentiate themselves from what they view as lower-quality competitors. “We're right on that border between a clinical device and a wellness device,” Hale said, while on the other end of the wellness spectrum is “snake oil – things that are of dubious value and maybe dubious quality in the worst case scenario”.
The Finnish health tech company recently launched its first randomised controlled clinical trial, which is the gold standard to test the safety and efficacy of new medical devices and treatments. For the study, researchers from the Kuopio Research Institute of Exercise Medicine in Finland will assess whether tailored exercise advice from Oura’s AI companion can help people reduce arterial stiffness – which happens as people age and is tied to – compared with regular fitness classes or no intervention at all. Beyond this type of preventative care, Hale said the ring’s sensors could also help with health screenings and diagnoses by detecting physiological changes that might take longer for a patient or their doctor to notice.
During the COVID-19 pandemic, for example, the company asked users to report if they got the virus, and researchers then worked backward to analyse data collected by the Oura ring, identify patterns, and create an algorithm that could identify COVID-19 about 2.75 days before people got tested. “If you wear this device all the time, and we're able to have a good picture of your baseline, and we can see those deviations from those baselines .
.. we're like, ‘something's going on, please see a doctor,’” Hale said.
“We call it the check engine light for your body,” he added. Notably, Oura hasn’t been approved by regulators in Europe or the US to help manage health conditions, and some doctors are sceptical that they will live up to the hype. Some worry, for example, that it could actually be unhealthy for people to obsess over their health metrics or that doctors won’t have access to data that could make a difference in someone’s medical care.
So far, research shows promising results – at least when it comes to fitness activity. For example, a covering nearly 200,000 people found that while the devices helped people lose weight and boost their activity levels, they did not improve blood pressure or cholesterol levels. Meanwhile, a spanning 1.
2 million people concluded that activity trackers “show promise in disease detection, with notable accuracy in identifying atrial fibrillation and COVID-19” but said more studies are needed to actually understand their potential benefits. Hale believes that helping people identify bad habits will prompt them to change their behaviours. Studies like the one launching in Finland will either prove him right – or send Oura and other wearables back to the drawing board.
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