Aktiia G0 cuffless blood pressure monitor now FDA approved

The Aktiia G0 blood pressure monitor has received US Food and Drug Administration (FDA) 510(k) clearance. This means that it has been deemed suitable for over-the-counter use by the federal agency. The company claims that it is the first cuffless blood pressure monitor to be approved for sale directly to consumers in this market.

Aktiia’s G0 blood pressure monitoring system is known as the Hilo Band in Europe following a rebrand earlier this year. The company indicates that it already has over 130,000 users in this region. Now, Aktiia is gearing up to launch this technology in the US.

The G0 or Hilo Band is a 24/7 blood pressure monitor, providing users with over 800 readings each month. The silicone wristband holds a blood pressure pod close to the skin, taking systolic and diastolic blood pressure measurements. The data is analyzed in real-time, with a historical log and benchmark comparisons available in the accompanying smartphone app. Users are also said to be able to see the impact of their exercise, meals and stress on their heart rate. However, it is worth noting that these advanced app-based features are only available for subscribers. The wearable is said to run for up to 15 days, with a full recharge taking around 90 minutes. 

Aktiia is expected to launch the G0 blood pressure monitor, or Hilo Band, in the US at some point in 2026. The company has yet to announce the pricing for this market; as a guide, the Hilo Band retails for £209.99/€229.99 (~$280) in Europe.