Executives with wearables firm Ōura are advocating for a new path to market that would allow health screening features to undergo less regulatory scrutiny.
Ōura, which makes a “smart ring” with several embedded wellness features, has been working on a functionality to flag signs of high blood pressure. The plans follow Apple receiving Food and Drug Administration clearance for a hypertension feature for its watch last year, and wearables firm Whoop receiving a warning letter for an unauthorized feature allowing users to measure their blood pressure.
As wearables become more sophisticated, with companies developing new uses that cross from wellness into regulated medical devices, figuring out where to draw the line can be challenging. In an opinion piece published in the Wall Street Journal last month, Ōura CEO Tom Hale proposed creating a new device classification for “digital health screeners” — features that can warn users about their health but stop short of diagnosis. However, patient groups still see an important role for regulators, with the nonprofit ECRI Institute noting in 2023 that unregulated wearables have varying degrees of accuracy and privacy, and research on the devices’ ability to predict health outcomes is lacking.
Ricky Bloomfield, who was appointed Ōura’s chief medical officer last year, spoke with MedTech Dive about Ōura’s plans for a hypertension feature and how the company envisions a new regulatory pathway.
This interview has been edited for length and clarity.
MEDTECH DIVE: How long has Ōura been thinking about this concept of digital health screeners?
RICKY BLOOMFIELD: We’ve been thinking about it for a number of years.
We released a feature called symptom radar [in 2024], which is a wellness feature. It can help someone understand if their vital signs are deviating from their baseline, which might indicate an illness of some sort. This was developed during COVID, and in that experience, what we realized is that there are a lot of different things that a feature like this could potentially help someone understand about their body.
We have been exploring many different ways to use the sensors on the device to find things that would otherwise be hidden.
Recently, we announced a study called blood pressure profile, which is basically a feature that can detect if someone has hypertension. And we’re taking this through some additional study steps, and then our plan is to submit that to the FDA.
There’s another analogous feature on the market already called hypertension notification from Apple. We think features like this are really important and different from prior devices that diagnose a condition, because these devices will screen and let you know if it’s likely that you have something, but stop short of diagnosis. The risk is lower, because you still have to go to your doctor to get that diagnosis confirmed, and the benefits are significant. Because of this, we think that there should be a better path to make this easier for companies like Ōura when they have features that have high benefit and lower risk. That’s why we’re proposing this middle pathway between the Class 1 or general wellness devices and Class 2 medical devices that have to go through the 510(k) or de novo process.
Will your feature be similar to Apple’s in that it doesn’t provide a specific blood pressure reading?
That’s exactly right, and that’s an important distinction in what we’re describing. The types of features that we are talking about are features that are screening for conditions, but not, in the case of blood pressure, providing a specific value. Devices that provide a systolic and diastolic blood pressure, I believe, would actually still fall into a Class 2 medical device, because those can be used to diagnose hypertension.
Features like our blood pressure profile study and like Apple’s hypertension notification don’t actually measure blood pressure at all. The way they work is [they] use that PPG [photoplethysmography] sensor on either the watch or the ring, and we can look at hundreds of thousands of people, both some who have hypertension and some who don’t. With a machine learning model, we can identify different features in the PPG morphology, or shape of that waveform, that would indicate that someone has high blood pressure.
With this regulatory framework you’re proposing, what evidence would you be providing to the FDA to show your screening tool is accurate?
There’s still a lot that would need to be discussed with the FDA. We put this proposal out there. We have had discussions with the FDA about other features that we are submitting through the existing process. We have not had discussions that have led to direct feedback from the FDA about this new proposal.
To give you a sense for what we’re thinking, because this new digital health screening pathway would exist between Class 1 and Class 2, it would probably share elements of both. It would be closer to Class 1 from the perspective of being mostly a self-registration with existing FDA enforcement discretion. However, we believe that it would pull in elements of Class 2, such as some of the design controls, having a [quality management] system, labeling, potentially post-market surveillance.
The way I envision this working is that devices could have their baseline sensors validated. For example, we could validate the accuracy of the PPG sensor, which measures heart rate, the blood oxygen sensor, the motion sensor, temperature sensors. And then, of course, we would still have to do all of the work to build and validate the feature. We still have to do the science, we still have to do the studies, we still have to do that in a large population to make sure that we hit certain specificity and sensitivity numbers. And of course, we’d be happy to share that with the FDA, and we would expect that they would want to see some of that. I think the difference is more like a Class 1, this would be for reference, rather than an explicit approval step, like a Class 2.
In the opinion piece, your CEO mentions a need for legislation to support this change. Is that something you anticipate?
We believe that the FDA could make most of these changes themselves, but these types of changes are always stronger if Congress acts and enshrines it into law. We appreciate the authority that the FDA has in regulating this space, but we look forward to working with Congress if they have questions about how this might work.
How are you navigating decisions between offering a wellness feature and going through the FDA under the current framework?
We take that on a case by case basis because every feature is very different. I already mentioned the symptom radar feature, which is a general wellness feature that we put out there. That feature was actually developed as part of a study during COVID. We found that this model was actually able to detect COVID 2.75 days earlier than a COVID test. But if we wanted to tell someone specifically that you may have COVID, that would have required a full Class 2 submission, likely a de novo in this case, because there isn’t really anything like that out there. And that would take years.
We had to consider, how can we have the biggest impact here? And we decided that by removing any specific claims of a certain condition being found and just keeping it generic — we tell someone you have either minor signs or major signs of illness — we can stay safely on the wellness side, but still let someone know that there’s something going on in their body.
But there are some cases where we do need to tell you something very specific, and I think blood pressure is a good example of that. We can’t just tell you, you have signs of a cardiovascular condition. That’s not really actionable. We really need to tell you that you may have high blood pressure, because there are specific things that you would need to do.
So that’s how we’re approaching it internally, trying to look at what [features] do we actually want to create the best experience we can for our members?
