Trusted by over 130,000 users globally, the Hilo Band has demonstrated the impact of Aktiia’s technology in real-world settings. With this FDA clearance, consumers in the U.S. will soon have access to the same clinically validated innovation behind the Hilo Band and app. With no medical prescription required, it is now the first cuffless blood pressure monitor authorized for over-the-counter use in the United States. The milestone sets a new global benchmark for how blood pressure can be effortlessly monitored through wearable, user-friendly technology. With this FDA clearance, Aktiia is now positioned to establish Hilo as the category-defining wearable for cuffless blood pressure monitoring in the U.S. and beyond.

“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.”