Neuchâtel-based healthtech company Aktiia has achieved a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its G0 blood pressure monitoring system, commercially known as the Hilo Band. This approval makes it the first cuffless blood pressure monitor authorized for over-the-counter (OTC) use in the United States, setting a new global benchmark for consumer blood pressure monitoring technology.
Revolutionary Technology Reaches U.S. Market
The Hilo Band utilizes optical sensors to continuously measure blood pressure without requiring a traditional cuff, representing a fundamental shift from conventional monitoring methods. Already CE-certified and available in Europe under the Hilo brand, the device combines clinical accuracy with a sleek, wearable form factor that enables effortless monitoring through user-friendly technology.
The FDA's clearance opens the U.S. market to consumers without requiring a medical prescription. The company plans to launch the Hilo Band in the United States in 2026, initially offering the device online to American consumers.
Proven Track Record and Scientific Foundation
Developed over more than seven years and building on two decades of research at the Swiss Research Institute CSEM, the Hilo Band has demonstrated significant real-world impact. The device is already trusted by over 130,000 users globally, providing validation for Aktiia's technology in practical settings.
"This is not just a regulatory win: it's the start of a paradigm shift in hypertension management," said Josep Sola, Co-Founder and CTO of Aktiia. "With FDA's OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions."
Mattia Bertschi, Co-Founder of Aktiia, emphasized the extensive development process: "This milestone is the result of more than seven years of relentless scientific, clinical, and engineering effort. What began as a research vision in the Swiss Research Institute CSEM twenty years ago has now become the world's first cuffless, FDA-cleared, over-the-counter solution for blood pressure – and we're just getting started."
Strong Financial Backing and Market Position
The regulatory clearance follows an oversubscribed Series B funding round of over $42 million USD completed earlier this year. The round was co-led by Earlybird Venture Capital and Wellington Partners, with continued support from Khosla Ventures and redalpine. Aktiia rebranded as Hilo in early 2025 following this successful funding round.
Dr. Christoph Massner, Principal at Earlybird and Board Director of Aktiia, highlighted the significance of the achievement: "Aktiia's FDA clearance represents a breakthrough moment for medical-grade wearables. We backed the team because they combined bold vision with scientific rigor; and today they've delivered what no one else could. The Hilo Band is poised to lead a global transformation in how we understand and manage cardiovascular health at scale."
Implications for Hypertension Management
The FDA clearance is expected to accelerate Aktiia's international growth and solidify its position in the emerging segment of cuffless blood pressure monitoring (CBPM). According to the company, this development marks a paradigm shift in how individuals monitor and manage hypertension, addressing one of the world's leading health challenges.
With this regulatory milestone, Hilo is now positioned to establish itself as the category-defining wearable for cuffless blood pressure monitoring in the U.S. and beyond. The company's progress reflects the growing role of Western Switzerland's Health Valley in advancing consumer-oriented medical technologies.
The FDA clearance enables Aktiia to establish a strong presence in the U.S. market while continuing to expand its platform's capabilities and applications, potentially transforming how millions of Americans approach cardiovascular health monitoring.
