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

Dr Jay Shah MD FACC is the Chief Medical Officer at Aktiia and has deep leadership expertise across healthcare delivery, leadership, and innovation. Dr Shah studied medicine at the University of Missouri-Kansas City School of Medicine and then completed a residency in Internal Medicine at Massachusetts General Hospital, followed by a fellowship in cardiovascular diseases at the Washington University School of Medicine.

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