FDA Clears First Over-the-Counter Cuffless Blood Pressure Monitor

The U.S. Food and Drug Administration (FDA) has granted clearance to the first cuffless blood pressure monitor available over-the-counter, marking a significant advancement in hypertension management technology. The Hilo wristband, developed by Swiss company Aktiia, utilizes optical sensors to provide continuous blood pressure readings without the need for traditional inflatable cuffs.

Revolutionary Technology Meets Regulatory Approval

Aktiia's Hilo bracelet employs innovative optical sensing technology to capture blood pressure measurements across various user positions and skin tones. The device, which requires only monthly calibrations, has demonstrated accuracy comparable to traditional cuff-based methods.

The FDA's clearance follows the product's earlier approvals in Europe, Canada, Australia, and Saudi Arabia. With over 120,000 units already sold globally, Aktiia plans to introduce the Hilo bracelet to the U.S. market in 2026.

Josep Sola, Aktiia's co-founder and chief technology officer, hailed the FDA clearance as "the start of a paradigm shift in hypertension management," emphasizing the potential for widespread adoption of cuffless monitoring technology.

Clinical Validation and User Preference

A recent clinical study conducted in collaboration with Mass General Brigham health system highlighted the Hilo bracelet's effectiveness and user acceptance. The study, which focused on patients with uncontrolled hypertension, found that 91% of participants preferred the smartphone-connected Hilo monitor over daily measurements with an inflatable cuff.

Researchers noted that the system could provide a platform for easy out-of-office blood pressure readings, potentially improving remote medication management for hypertensive patients.

Financial Backing and Future Prospects

Aktiia's technological breakthrough has attracted significant investor interest. In early May, the company secured $42 million in a Series B funding round co-led by Earlybird Health and Wellington Partners. The investment, which included participation from several venture capital firms, underscores the growing confidence in Aktiia's innovative approach to blood pressure monitoring.

Christoph Massner, principal at Earlybird and Aktiia board director, expressed optimism about the company's future, stating, "The Hilo Band is poised to lead a global transformation in how we understand and manage cardiovascular health at scale."

As Aktiia prepares for its U.S. launch, the Hilo bracelet stands at the forefront of a new era in wearable medical devices, promising to revolutionize hypertension management and cardiovascular health monitoring.