Aktiia’s Hilo Band has become the first cuffless blood-pressure monitor cleared by the US FDA for over-the-counter (OTC) use.

Swiss firm Aktiia it has received US Food & Drug Administration (FDA) 510(k) clearance for OTC use of its cuffless blood-pressure monitoring technology. This clearance, granted for its G0 blood-pressure monitoring system, marks the first time the FDA has cleared a cuffless blood-pressure monitor indicated for OTC use in the USA.

While the product is already CE marked and available in Europe under the brand Hilo, it will be made available to US consumers from next year.

Used by more than 130,000 people globally, the Hilo Band and app have demonstrated the impact of the technology in real-world settings.

“This is not just a regulatory win, it’s the start of a paradigm shift in hypertension management,” said Josep Sola, 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, added: “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 option for blood pressure, and we’re just getting started.”

This regulatory clearance follows an oversubscribed series B round of over $42m co-led earlier this year by Earlybird Venture Capital and Wellington Partners.

“Aktiia’s FDA clearance represents a breakthrough moment for medical-grade wearables,” said Christoph Massner, principal at Earlybird and board director of Aktiia. “We backed the team because they combined bold vision with scientific rigour, 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.”

Due to its sleek, lightweight and comfortable form factor, the Hilo Band is said to usher in a class of medical wearables that empower individuals to monitor their blood pressure anytime, anywhere.

Founded in 2018, Aktiia is transforming the way blood pressure is measured and managed. By harnessing one of the world’s largest datasets of optical signals, its Hilo Band cuffless monitoring product provides clinically meaningful insights to individuals and healthcare professionals, making blood-pressure tracking more accessible and effortless.

With billions of optical signals and hundreds of millions of blood-pressure readings collected from more than 130,000 users, Aktiia has developed a robust and scalable way to address one of the world’s most pressing health challenges. Hypertension affects more than 1.3 billion people globally and remains the leading risk factor for cardiovascular disease, yet most cases remain undiagnosed or poorly managed. By enabling seamless and user-friendly monitoring at home, Aktiia wants to transform how hypertension is detected and managed worldwide.

The product is supported by more than 120 peer-reviewed publications and over 35 patents. Headquartered in Switzerland, the company is expanding internationally to make accessible, cuffless blood-pressure monitoring the standard of care in home hypertension management.

The Hilo Band (www.hilo.com) requires calibration using a cuff, which is provided with the purchase.