Hilo by Aktiia Received FDA 510(k) Clearance for its Blood Pressure Monitor Wristband

The CSEM spinoff Aktiia has received FDA 510(k) clearance for its over-the-counter cuffless blood pressure monitor, G0 Blood Pressure Monitoring System, also known as the Hilo Band. Thi wearable uses an optical sensor to collect data from one’s wrist.

The Hilo by Aktiia wrist wearable is one of a kind as it collects one’s blood pressure throughout the day, but does so only when they are still. It examines the unique form of pressure exerted by each heartbeat through the wearer’s blood vessels. That data is then sent to the Hilo app, an algorithms estimate the wearer’s blood pressure using pulse wave analysis.

The product, which isalready CE marked as a Class IIa medical device for monitoring blood pressure in adults in Europe, will be available to U.S. consumers in 2026.

“This milestone is deeply personal for us as founders and profoundly important for everyone at Aktiia. From day one, our mission has been to tackle the global hypertension crisis through technology. With this FDA clearance, we’re one step closer to realizing our vision: a future where healthy blood pressure is accessible to all,” Dr. Josep Solà, cofounder and chief technology officer at Aktiia, told MobiHealthNews.

In May2026, Aktiia scored a CHF 34 million in an oversubscribed Series B funding round, bringing its total raise to more than $100 million.

Last year, Aktiia completed a CHF 27 million funding round and received CE mark in Europe for its calibration-free technology CALFREE, which allows blood pressure data to be collected using inputs from optical sensors commonly found in smartwatches and cameras of commercial smartphones.

In 2021, the company raised $17.5 million in Series A funding, and the year before, it secured $6.1 million (CHF 6 million) in funding.

➡️ Source: MobiHealthNews | 📸 Hilo by Aktiia