First Cuffless Blood Pressure Monitor Cleared By FDA Hailed As A Paradigm Shift
Aktiia, a pioneer in continuous blood pressure monitoring, has secured FDA 510(k) clearance for its medical-grade G0 Blood Pressure Monitoring System, marking a significant leap forward for cardiovascular health technology. This approval makes the Hilo bracelet the first-ever cuffless blood pressure monitor to be cleared for over-the-counter use in the United States, potentially landing this tool into more hands than before.
Josep Sola, CTO and co-founder of Aktiia, expressed his enthusiasm on LinkedIn, reflecting on the journey in reaching this milestone, quoting one of its investors, "Some things are too important not to try. So I'd rather try and fail... than fail to try."
Sola also noted (in a press release), "This is not just a regulatory win: it’s the start of a paradigm shift in hypertension management. With FDA’s OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions."
This FDA clearance is not Aktiia's first regulatory triumph. though; the Hilo system has already received CE Mark approval in Europe and has been approved in Canada, Australia, and Saudi Arabia, with over 120,000 units already sold globally.
Aktiia, founded in 2018, supported its regulatory submission with a comprehensive clinical trial involving 140 patients. The company anticipates making the Hilo bracelet available to U.S. consumers in 2026, which could lead to democratized access to continuous blood pressure monitoring for millions.
The FDA clearance comes on the heels of a successful Series B venture capital fundraising round for Aktiia in early May, where the company secured over $42 million. No doubt this investment will fuel Aktiia's efforts to bring the Hilo bracelet to market faster, as well as the development of the company's future innovations.
