News

FDA Clears First Over-the-Counter Cuffless Blood Pressure Monitor for U.S. Market

• By John K. Waters
• 07/14/2025

Swiss health technology company Aktiia has received FDA 510(k) clearance for its G0 Blood Pressure Monitoring System, becoming the first cuffless blood pressure monitor approved for over-the-counter use in the United States.

The Hilo bracelet, worn like a wristwatch, uses optical sensors to continuously measure blood pressure through photoplethysmographic (PPG) signals from arteries. The device requires monthly calibrations using an included dock but eliminates the need for traditional inflatable cuffs during regular monitoring. PPG is a non-invasive optical technique used to measure blood volume changes in the microvasculature. It works by detecting variations in light absorption and reflection as blood flows through the tissue, allowing for the monitoring of various physiological parameters like heart rate and oxygen saturation.

Technology Addresses Long-Standing Challenge
Cuffless blood pressure monitoring has been viewed as a priority for the wearable health industry, given that hypertension affects nearly half of U.S. adults and is a leading cause of death worldwide. Traditional cuff-based monitors, while accurate, present limitations including physical discomfort and the inability to provide continuous readings.

The technology measures pulse wave characteristics to estimate blood pressure, part of a broader field that has seen significant research growth. Studies indexed in PubMed show 951 papers on cuffless blood pressure monitoring through November 2024, reflecting increased academic and commercial interest.

However, achieving clinical performance standards has remained challenging for the technology. Many cuffless devices still require calibration against traditional cuff measurements, and performance can vary between users due to physiological differences.

Clinical Validation and Market Reception
Aktiia supported its FDA submission with a clinical trial involving 140 patients. A separate study conducted with Mass General Brigham found that 91% of patients with uncontrolled hypertension preferred the smartphone-connected Hilo system over daily inflatable cuff measurements for remote medication management.

The company has already achieved regulatory approvals in Europe, Canada, Australia, and Saudi Arabia, with over 120,000 units sold globally. Founded in 2018, Aktiia raised over $42 million in Series B funding in May.

"This is not just a regulatory win: it's the start of a paradigm shift in hypertension management," said Josep Sola, CTO and co-founder of Aktiia, in a statement."With FDA's OTC clearance, we are breaking down the barriers that have kept cuffless blood pressure monitoring out of the hands of millions."

Market Implications
The FDA clearance represents a significant milestone for cuffless blood pressure monitoring technology, which has faced regulatory hurdles despite years of development. Multiple approaches exist for cuffless monitoring, including photoplethysmography, pulse transit time measurement, and bioimpedance analysis.

Recent studies suggest that cuffless blood pressure devices can enhance hypertension management by providing continuous monitoring capabilities that traditional devices cannot offer. The technology's integration into wearable devices could enable better detection of blood pressure variability and medication adherence monitoring.

Aktiia plans to make the Hilo bracelet available to U.S. consumers in 2026. The company claims the device offers accuracy comparable to conventional cuff measurements while providing the convenience of continuous monitoring with minimal user intervention.

The approval comes as the wearable health monitoring industry continues to expand, with companies seeking to develop non-invasive monitoring solutions for various cardiovascular conditions beyond blood pressure measurement.