Cuffless blood pressure tracking Hilo Band set for US release after FDA nod
Just approved by the FDA, Aktiia’s cuffless blood pressure wearable will hit the US market in 2026. Already available in Europe, the device collects data from the wrist and estimates blood pressure without the need for a traditional cuff.
A wrist-based monitor with clinical ambitions
The Swiss-based company has been in this space for a few years now. I reviewed the original Aktiia bracelet back in 2021 and was impressed by how well it performed. It focused entirely on blood pressure and resting heart rate, and it did that pretty well. The form factor was compact, easy to forget once it was on the wrist, and the readings were solid.
Now that same core idea is headed for US approval under a slightly different name. The device will go by the label G0 Blood Pressure Monitoring System locally, but it’s essentially the same as the current version called Hilo Band already being sold in Europe. And like before, it relies on an optical sensor that sits on the wrist and captures blood flow data. The data gets sent to the Hilo app and processed on Aktiia’s servers using pulse wave analysis algorithms.
Continuous tracking, when you’re still
The company’s approach differs from traditional cuff-based systems in one key way. Rather than asking you to take a reading manually each time, the Hilo Band collects data in the background. You need to be still for it to work, which makes sense given the sensitivity required. But it means you can wear it day and night and still get a stream of measurements that reflect your blood pressure trends over time.
This can be particularly useful for people managing hypertension, or for those who simply want better awareness of their cardiovascular metrics. In my original review, I found the bracelet would deliver about 10 readings in a 24-hour period, which was more than enough to build a picture of how my blood pressure varied through the day and night.
FDA clearance, with US launch set for 2026
The FDA 510(k) clearance marks an important milestone for the company. The Hilo Band already has the CE Mark as a Class IIa medical device in Europe, where it has been available for some time. This latest approval clears the way for the product’s US debut, which Aktiia says is scheduled for 2026.
It’s worth noting this remains a medical-grade product, not a general-purpose fitness wearable. It doesn’t try to count steps or measure your VO2 max. It sticks to what it was designed for, which is automated, cuffless blood pressure tracking using clinical algorithms.
Check it out on the Hilo website.
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