Where Wearables and the FDA Collide: The Future of Blood Pressure Monitoring

Where Wearables and the FDA Collide: The Future of Blood Pressure Monitoring

As wearable technology continues to advance, devices are becoming more ambitious, moving from step counting and sleep tracking to measuring core health metrics like blood pressure. But with that evolution comes growing oversight. Increasingly, health focused features are drawing the attention of regulators like the US Food and Drug Administration (FDA), especially when those features begin to resemble clinical tools.  

This is particularly relevant for non-invasive blood pressure monitoring, which is argued to sit at the intersection of wellness insight and medical grade accuracy. The way forward is no longer just about innovation. It is about trust, validation, and clear clinical pathways. 

Wellness vs Medical Where the FDA Draws the Line 

Under existing FDA regulations (21 CFR § 870.1130), any device that displays or interprets blood pressure data may be classified as a medical device, depending on its intended use. This includes wellness wearables, especially when the functionality appears diagnostic, regardless of disclaimers. 

What this means in practice is that any wearable claiming to show blood pressure readings or trends can face scrutiny if it does not have appropriate clearance. That puts pressure on wellness focused brands to walk a fine line between informing users and complying with medical regulations. 

 Estimation vs Measurement Why It Matters 

The vast majority of wearables today rely on estimation algorithms. These might use proxy indicators like heart rate, pulse transit time, or optical signals to deliver an approximate blood pressure range. While these can offer useful trends, they are not substitutes for direct measurement and in many cases cannot be used in medical decision making. 

This distinction is becoming more than technical. It is regulatory. 

 As scrutiny increases, the difference between helpful wellness insight and unauthorised medical claim is being enforced with greater clarity. For health tech companies, the only sustainable path is to either operate clearly within the wellness space or commit to the journey of regulated clinical grade accuracy. 

In the News – A Growing Spotlight on Blood Pressure Innovation 

Recent developments show how active this space has become. Earlier this year, WHOOP received a warning letter from the FDA regarding its Blood Pressure Insights  feature. The company publicly responded, asserting that the feature provides estimated blood pressure ranges based on passive overnight trends and is not intended for medical use. 

Despite disclaimers, the FDA determined that the feature may fall under medical device regulations. This dispute has ignited debate across the wearable sector around how data is labelled, how intended use is interpreted, and what level of accuracy is expected when presenting health information. 

Similarly, Aktiia, the Swiss based blood pressure wearable brand, recently rebranded as Hilo and continues to market its wrist worn optical blood pressure technology. Aktiia’s system, like many others, relies on cuff based calibration and estimation models, offering users long term tracking rather than direct moment to moment measurement. 

 While these companies are at the forefront of pushing blood pressure into daily life, their technologies are fundamentally based on models and assumptions, rather than raw physiological measurement. 

 A Different Approach Direct Measurement with Ultrasound 

Novosound, a Scottish based deep tech ultrasound company, is taking a different route. 

Rather than estimating blood pressure using proxies, novosound is developing a wearable ultrasound sensor that captures direct measurements of arterial distension. This allows the device to measure blood pressure in real time using continuous waveforms, not inferred metrics. No cuff, no estimation, no optical guesswork. 

The underlying technology is based on established medical ultrasound principles, adapted into a soft, wearable format for everyday use.  

“Our sensor directly measures arterial distension to determine blood pressure,” said Dr Dave Hughes, CEO of Novosound, in response to recent industry commentary. “We believe there is a need for truly accurate data, delivered noninvasively and continuously, and we have built our technology with regulatory approval in mind from the beginning.“

Built for the FDA  

Many consumer health companies are now facing the difficult transition from wellness tracker to medical device. That journey comes with significant demands including clinical validation, regulatory filings, manufacturing standards, and quality systems. 

Novosound has approached this from the start with a clear vision. The company is currently pursuing FDA clearance for its wearable ultrasound blood pressure solution. The intention is not to retrofit wellness tools into the medical space but to deliver purpose built, medically approved innovation.  

“Trends in recent tech incorporating health centric features have increasingly fallen under the jurisdiction of the FDA,” said Dr Dave Hughes. “This is particularly relevant in monitoring health critical metrics such as blood pressure. We are ready for that. FDA clearance has always been on our roadmap.“

What This Means for the Industry 

The FDA’s increased attention to blood pressure features in wearables is not a barrier to innovation. It is a filter. It is pushing the industry to separate estimation from accuracy, and speculation from measurement. That shift may challenge business models, but it ultimately benefits the most important stakeholder, the user. 

In this next phase of wearable health tech, measurable accuracy will be the benchmark. Whether you are building for athletes, clinicians, or the general public, real data, validated and verified, is the only path to long term impact. 

Partnership Potential 

As the health wearables sector matures, collaboration will be key. Rather than competing with existing smartwatch and fitness tracker brands, novosound is actively exploring opportunities to integrate its wearable ultrasound technology into existing platforms. Whether through licensing, hardware partnerships, or co-development, the aim is to bring direct blood pressure measurement to market at scale, quickly and responsibly. 

For forward-looking device makers and health platforms, this offers a path to leapfrog estimation and unlock true clinical potential, without having to reinvent core sensing hardware. 

Final Note  

We wrote this piece to contribute constructively to an important and rapidly evolving conversation. It is not intended as a critique of any one company, but as a reflection of the regulatory reality all wearable innovators now face. We respect the work of others in the field, and believe in a future where clinical grade technologies and wellness innovation can align. 

We expect this space and regulation within it to continue evolving. As it does, we will adapt, improve, and keep building toward our goal of delivering truly accurate, non-invasive blood pressure measurement that meets the highest medical standards. 

To learn more about novosound’s wearable ultrasound technology or explore potential collaboration, contact us at  info@novosound.net.