Why Cogwear is leaning into FDA clearance, even as others push back
When the FDA recently issued a warning letter to Whoop over its Blood Pressure Insights feature, a wave of debate swept through the wearables industry. Will Ahmed, CEO of Whoop, responded publicly, calling the FDA’s move “misguided” and “an example of regulatory overreach.” His post argues that intended use matters, that blood pressure estimates should be treated like heart rate data and wellness features, not medical claims.
I respect what Whoop has built. They’ve created one of the most recognized consumer wearables on the market and have successfully taken features like their ECG monitor through the FDA clearance process. That’s no small feat. But in this case, I believe their interpretation of the rules and their rationale for sidestepping clearance for blood pressure insights is flawed.
They argue that blood pressure should be treated like heart rate: a general wellness metric that can offer directional insight without diagnosing a condition. But here’s the critical difference. Heart rate can signal a range of issues, but it’s not itself a diagnostic. Blood pressure, on the other hand, is the clinical standard for identifying hypertension. If you show someone a blood pressure reading, estimated or not, you’re in the realm of medical guidance, not just wellness feedback.
The industry debacle: where does “wellness” end and “medical” begin?
This incident highlights a long-standing tension in our industry. Are wearable wellness tools or medical devices? In 2022, the FDA clarified that line with a new updated policy.
If your product offers general lifestyle insights—like rest, recovery, or stress trends—it falls under the “wellness” category. But if you identify or imply a medically recognized condition like hypertension, anxiety, or concussion, you're entering medical device territory. And that means you need FDA clearance.
Where consumer wearables are getting it wrong
The term “wellness” has become a catchall. But let’s be honest, most consumer devices today are performance devices. They’re optimized for improving sleep, stamina and training gains. That’s not necessarily “wellness” in the holistic, clinical sense. It’s human performance.
Now in search of their next growth areas, many of these companies are drifting into health territory without the infrastructure or regulatory understanding needed to do it correctly. The FDA warning letter to Whoop is a signal that this drift has gone too far.
We’re not surprised. Consumer-first companies, often born in Silicon Valley, are bumping into FDA requirements without a company culture built around medical safety and quality. It’s not enough to build great UX or elegant design. If you’re entering healthcare, you have to be built for doctors and patients, not just users.
That’s why Cogwear is taking a different path. We are very careful about FDA’s guidance as we pursue clearance for our product. Because when you build for health, not just performance, you have a responsibility to get it right.
Why we won’t cut corners
Some investors ask why we are going for both medical and consumer pathways. We believe the incremental effort and engineering discipline are worth it to not limit the experience and capabilities for Cogwear users, our company, and investors.
Our goal is to deliver clinical-grade, real-time brain insights that can be used on a day-to-day basis to improve cognitive performance and, for instance, can also be used to detect signs of concussion. Here’s an example. A soccer player could wear our headband to help improve their focus on the field and, at the same time, use it to monitor for potential injuries from heading the ball.
We’re choosing to:
Meet FDA directives for safety, efficacy, and intended use.
Test, validate, and document our algorithms to the highest standards.
Deliver data that clinicians can trust, not just trends that consumers hope are accurate.
Safety, trust, and leadership
The warning letter to Whoop is not a one-off. The FDA has been crystal clear: if you want to reference conditions, injuries, or disorders in your device output, you need clearance.
Apple understood this years ago. In November 2021, Apple secured FDA 510(k) clearance for its irregular heart rhythm notification on the Apple Watch, a milestone that allowed the company to position part of its wearable as a medical device. And Apple didn’t stop there. In 2024, they went a step further to further clear that same technology for use in clinical trials, reinforcing its credibility and cementing the Apple Watch as more than just a wellness gadget.
Cogwear is following that model because our mission demands it. We’re building a device that athletes, patients, and families can rely on. We’re not just selling insights; we’re delivering actionable, medical-grade information that will create meaningful outcomes for people.
A word to investors and partners
I know some of you have wondered why we are navigating both the consumer and medical markets. The answer is simple. Separating wellness from healthcare is a misnomer and limitation on growth. We want our products to be the best. They won’t dance around potential healthcare claims and will be used in the most rigorous applications. Our technology will serve consumers and clinicians alike with FDA-backed safety and reliability.
We are not chasing headlines. We are building a future where cognitive health data is trustworthy, regulated, and transformative. And when the FDA is rightly watching your every move, as they inevitably are in this space, you want to be able to look them in the eye and say we did this the right way.
CAUTION - Investigational device. Limited by Federal (or United States) law to investigational use.
