Aktiia, a Swiss pioneer in optical blood pressure monitoring, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for over-the-counter (OTC) use of its cuffless blood pressure monitoring tech.

The FDA nod was awarded to the company’s G0 blood pressure monitoring system, marking the first time the FDA has cleared a cuffless blood pressure monitor indicated for OTC use in the U.S. Aktiia’s blood pressure monitoring products are already CE marked and sold in Europe under the Hilo brand—it will become available in the U.S. in 2026.

The Hilo Band has a sleek, lightweight, and comfortable form factor, empowering people to monitor their blood pressure anytime and anywhere, according to the company.

“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.”

The company hopes that this milestone will set a new benchmark for how blood pressure can be easily tracked through wearable, user-friendly technology.

“This milestone is the result of more than seven years of relentless scientific, clinical, and engineering effort,” said Mattia Bertschi, co-founder of Aktiia. “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.”

The regulatory clearance follows an oversubscribed Series B financing round of more than $42 million 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 Dr. Christoph Massner, Principal at Earlybird and Board Director of Aktiia. “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.”