Aktiia Gets FDA Clearance For OTC Cuffless Blood Pressure Monitor

Healthcare technology company Aktiia has received FDA 510(k) clearance for its over-the-counter, cuffless blood pressure monitor — the G0 Blood Pressure Monitoring System, also known as the Hilo Band. Already marketed under the Hilo brand in Europe, Aktiia’s system is a wrist-worn wearable that uses an optical sensor to collect data. This data is sent to the Hilo app and cloud server, where algorithms estimate blood pressure using pulse wave analysis. According to the company, the analysis examines the unique pressure pattern generated by each heartbeat as it moves through the wearer’s blood vessels. The wearable continuously monitors blood pressure throughout the day, but only takes readings when the user is at rest. The device, which is already CE marked in Europe as a Class IIa medical device for adult blood pressure monitoring, is expected to be available to U.S. consumers in 2026.

Commenting on the milestone, cofounder and CTO Dr. Josep Solà told MobiHealthNews that the FDA clearance brings the company closer to its mission. “This milestone is deeply personal for us as founders and profoundly important for everyone at Aktiia. From day one, our mission has been to tackle the global hypertension crisis through technology. With this FDA clearance, we’re one step closer to realizing our vision: a future where healthy blood pressure is accessible to all,” he said. Solà emphasized the significance of the FDA’s decision to approve the device for over-the-counter use without a prescription, calling it “a rare and demanding bar to meet — a clear signal that our technology is not only clinically validated but ready for real-world, large-scale deployment.”

CEO and cofounder Dr. Mattia Bertschi added that the clearance opens up new opportunities. “This opens a new market for us, but more importantly, it confirms that Aktiia’s solution is safe, intuitive, and designed for the people who need it most. We believe this is just the beginning, and that cuffless, wearable, and over-the-counter blood pressure monitoring will soon become the global standard,” Bertschi said. He noted that the team is working “day and night to ensure that Hilo by Aktiia doesn’t just participate in this transformation … but leads it.”

This milestone follows a period of significant growth for the company. In May, Aktiia raised $42 million in an oversubscribed Series B funding round, bringing its total funding to more than $100 million. Last year, it completed a CHF 27 million (around $30 million) round and received a CE mark in Europe for its calibration-free CALFREE technology, which enables blood pressure monitoring using optical sensors commonly found in consumer devices like smartwatches and smartphone cameras. Aktiia said this approval allows it to offer its medical-grade blood pressure monitoring to third-party manufacturers, facilitating integration into wearable devices, cameras, and smart bands.

Since its founding in 2018 as a spin-out from Swiss research and development center CSEM, Aktiia has raised $17.5 million in Series A funding in 2021 and $6.1 million (CHF 6 million) the year before. The company continues to position itself as a leader in the global transformation of blood pressure monitoring technology.

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