‘The start of a paradigm shift’: FDA clears first over-the-counter cuffless blood pressure monitor
Aktiia, a Swiss medtech company that recently started trading under the name Hilo, has received U.S. Food and Drug Administration (FDA) clearance for the over-the-counter use of its cuffless blood monitoring technology. The Hilo Band, which has already gained CE mark approval, should make its U.S. debut in 2026.
The Hilo Band was designed with patient comfort in mind and works with a smartphone app that helps patients stay on top of their health at all times. Users calibrate the device using a provided cuff to get started, but then the cuff no longer needs to be worn. According to Aktiia, the Hilo Band’s impact on the hypertension market will be comparable to what the launch of Apple’s first iPhone meant for mobile phone technology.
“This is not just a regulatory win: it's the start of a paradigm shift in hypertension management,” Josep Sola, co-founder and chief technology of Aktiia, said 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.”
“This milestone is the result of more than seven years of relentless scientific, clinical and engineering effort,” added Mattia Bertschi, co-founder of Aktiia. “What began as a research vision in the Swiss Research Institute CSEM twenty years ago has now become the world's first cuffless, FDA-cleared, over-the-counter solution for blood pressure—and we're just getting started.”
In May, Aktiia announced the completion of a Series B funding round worth $42 million. At the time, the company said the new funds would go toward ongoing product development, expanding into new markets and building out its blood pressure intelligence platform.
“With billions worldwide suffering from hypertension, only 20% of whom are in control of their blood pressure, the need for innovative, accessible blood pressure monitoring solutions has never been greater,” Hilo CEO Raghav “Rags” Gupta said at the time.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.