Aktiia's Hilo Band: FDA Clears First Cuffless Blood Pressure Monitor for Over-the-Counter Use

The FDA-cleared G0 Blood Pressure Monitoring System, marketed as Hilo Band, will introduce cuffless blood pressure monitoring to U.S. consumers. Aktiia, a pioneer in optical blood pressure monitoring, has received FDA clearance for over-the-counter (OTC) use of its cuffless blood pressure monitoring technology. This clearance for Aktiia's G0 Blood Pressure Monitoring System is the first of its kind in the United States. The product, already available in Europe under the brand Hilo, will be accessible to U.S. consumers in 2026.

Trusted by over 130,000 users globally, the Hilo Band showcases the impact of Aktiia's technology in real-world scenarios. With this FDA clearance, U.S. consumers will soon have access to the clinically validated innovation behind the Hilo Band and app. This marks the first cuffless blood pressure monitor authorized for over-the-counter use in the U.S., setting a new standard for effortless blood pressure monitoring through wearable technology. Aktiia aims to establish Hilo as the leading wearable for cuffless blood pressure monitoring globally.

Josep Sola, Co-Founder and CTO of Aktiia, stated, \"This is not just a regulatory win: it's the start of a paradigm shift in hypertension management.\" Mattia Bertschi, Co-Founder of Aktiia, added, \"What began as a research vision has now become the world's first cuffless, FDA-cleared, over-the-counter solution for blood pressure.\"

The FDA clearance follows a successful Series B funding round of over $42 million USD. Dr. Christoph Massner, Principal at Earlybird and Board Director of Aktiia, commented, \"Aktiia's FDA clearance represents a breakthrough moment for medical-grade wearables.\" The Hilo Band is a significant advancement in cardiovascular health monitoring, offering a new class of medical wearables for convenient blood pressure monitoring.

Aktiia, founded in 2018, is revolutionizing blood pressure measurement and management. The Hilo Band provides clinically meaningful insights to individuals and healthcare professionals, making blood pressure tracking more accessible. With a vast dataset and deep expertise, Aktiia aims to transform how hypertension is detected and managed globally.

According to the source: Newswire Canada.