Aktiia’s Hilo band becomes first cuffless blood pressure monitor cleared by FDA

Neuchâtel-based Aktiia has received FDA clearance for its Hilo Band, marking a global first in cuffless blood pressure monitoring for consumer use.

Healthtech company Aktiia has achieved a major milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for the over-the-counter (OTC) sale of its G0 blood pressure monitoring system, known commercially as the Hilo Band. This makes it the first cuffless blood pressure monitor authorized for OTC use in the United States.

Already CE-certified and available in Europe under the Hilo brand, the device uses optical sensors to continuously measure blood pressure without the need for a traditional cuff. The FDA’s clearance now opens the U.S. market to consumers without requiring a medical prescription. The Hilo Band will be launched in the U.S. in 2026 and initially offered online.

Developed over more than seven years and building on two decades of research at CSEM, the Hilo Band combines clinical accuracy with a sleek, wearable form factor. Aktiia, which rebranded as Hilo in early 2025 after raising USD 42 million in an oversubscribed Series B round, has already sold over 130,000 devices worldwide.

A new class of medical-grade wearable devices

The FDA clearance is expected to accelerate the company’s international growth and further solidify its position in the emerging segment of cuffless blood pressure monitoring (CBPM). According to the company, this marks a paradigm shift in how individuals monitor and manage hypertension, one of the world’s leading health challenges.

The Series B round was co-led by Earlybird Venture Capital and Wellington Partners, with continued support from Khosla Ventures and redalpine. Commenting on the FDA milestone, Earlybird’s Christoph Massner described the Hilo Band as “poised to lead a global transformation in how we understand and manage cardiovascular health at scale.”

Aktiia’s progress reflects the growing role of Western Switzerland’s Health Valley in advancing consumer-oriented medical technologies. With this FDA clearance, Hilo now aims to establish a strong presence in the U.S. while continuing to expand its platform’s capabilities and applications.