Hilo by Aktiia: First cuffless blood pressure monitor cleared by the FDA

Last reviewed:
09 Jul 2025,
aktiia-hilo-fda-510k-otc

On July 2nd, the FDA cleared Aktiia’s G0 Blood Pressure Monitoring System — the first-ever cuffless monitor approved for direct consumer access in the U.S. This milestone sets a new standard in wearable cardiovascular tech, ahead of players like Apple.

CTO and co-founder Josep Sola shares [LinkedIn] what it took to reach this milestone — and why it was worth pushing through the doubt.

Read the full press release [PDF].

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Traditional blood pressure cuff vs. Hilo

Cuff

Hilo

Meets ISO81060-2 Standard
Day-Time Blood Pressure
Average 70+
measurements a week
Night-Time Blood Pressure
Automatic Measurements

About the Author

Piotr Kudela is a data science and digital marketing specialist with a strong interest in health technology. He combines his expertise in SEO and search marketing with insights from blood pressure research and health wearables. With a solid academic background and professional experience, Piotr aims to contribute to advancements in health through technology.

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