MedTech Dive August 20, 2025
Aktiia received FDA clearance in July for the first cuffless blood pressure monitor authorized to be sold over the counter.
In July, the Food and Drug Administration authorized the first over-the-counter cuffless blood pressure monitor.
The Hilo Band, made by Aktiia, uses an optical sensor to continuously track blood pressure. The wrist-based device must regularly be calibrated using a blood pressure cuff, according to the FDA’s 510(k) summary.
Aktiia has been selling the device in Europe after receiving a CE mark in 2021, and the company plans a U.S. launch in 2026.
Josep Solà, Aktiia’s co-founder and chief technology officer, spoke with MedTech Dive about the process of developing a cuffless blood pressure monitor and getting it cleared for over-the-counter...
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