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

Written byPiotr Kudela

Medically reviewed byDr. Tomas Bothe, M.D., Ph.D.

Published Jul 9, 2025 · 1 min read

By Piotr Kudela · Reviewed by Dr. Tomas Bothe Jul 9, 2025 · 1 min read

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].

Medically reviewed by Dr. Tomas Bothe, M.D., Ph.D.Chief Medical Officer, Hilo. All articles in the Hilo Resource Hub are medically reviewed.

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Hilo users with high or very high blood pressure were able to reduce their systolic readings by up to 7 mmHg after just 6 months of monitoring with Hilo.
Hilo Bracelet G1 has been CE-marked under the Medical Device Regulation (EU)2017/745 as a class IIa medical device.
Average weekly number of cuff readings according to Hilo survey of 1,337 blood pressure cuff users. For Hilo, actual number of measurements displayed per week may vary, as the Hilo App will discard readings with insufficient signal quality. Successful readings are often averaged together for easier viewing in the Hilo App.
Frequent errors in using BP cuffs can be as a result of body or cuff positioning, activity level before or during measurement, and many other factors. Hilo will not display readings when non-optimal conditions are detected, and accuracy has been demonstrated via multiple clinical trials.
Rated IP68 Water proof. The Hilo Band can be worn when dishwashing, splashing, showering or swimming. However, it cannot be used for diving or snorkeling.
In total 4 clinical trials were required during the design, development and validation of Hilo technology. Of these, 2 clinical trials supported the validation of the Hilo device for CE marking purposes.