Hilo, formerly known as Aktiia, has achieved a major regulatory breakthrough with the U.S. Food and Drug Administration granting 510(k) clearance for its cuffless Blood Pressure Monitoring System. Marketed as the Hilo Band, this approval marks the first time a cuffless wearable blood pressure monitor has been cleared for over-the-counter use in the United States.
This milestone enables consumers to access clinically validated, continuous blood pressure monitoring without the need for a traditional cuff. The device leverages optical sensors and proprietary algorithms to deliver real-time insights, offering a more comfortable and accessible alternative to conventional methods.
For Hilo, the FDA clearance is not only a product milestone but a signal of market readiness. With this green light, the company is poised to launch in the U.S. in 2026, paving the way for broader adoption of intelligent, non-invasive cardiovascular monitoring solutions.
The decision also affirms Hilo’s technological and regulatory maturity. It follows prior CE markings and international approvals, and builds on the momentum of a recently completed pivotal clinical trial. The Hilo Band has already seen wide interest, with more than 120,000 units sold to date globally.
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