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Aktiia Receives Regulatory Approval for the World’s First Optical Blood Pressure System Without the Need for Calibration with a Regular Cuff

Piotr Kudela • 12 Jun 2024 • 1 min read
Aktiia Receives Regulatory Approval for the World’s First Optical Blood Pressure System Without the Need for Calibration with a Regular Cuff

We’re thrilled to announce that Aktiia has received regulatory approval (CE mark) for our revolutionary optical blood pressure (BP) monitor that requires NO calibration with a regular cuff.

Approval of the CALFREE™ technology sets the stage for Aktiia to transform BP monitoring and management by enabling the integration of a medical-grade blood pressure system into a wide range of consumer devices (smartwatches, smartbands, and smartphone cameras), dramatically changing the ease and convenience of collecting data on one of the most impactful vital signs – blood pressure.

“This regulatory approval of Aktiia’s CALFREE technology is the realisation of a lifetime of work and a crucial step towards achieving our ultimate dream – to improve BP management and reduce the impact of hypertension on global health,” said Dr. Josep Sola, CTO and Co-founder of Aktiia.

Link to the full PR Release here.

Link to the Media Package here.

Please note: While we are announcing regulatory approval for the CALFREE device today, it is not yet commercially available. Stay tuned for updates!

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Piotr Kudela

About the author

Piotr Kudela

Health Content Editor, Hilo by Aktiia

Piotr Kudela is Health Content Editor at Hilo by Aktiia. Since joining Aktiia in July 2022, he has worked on health content focused on blood pressure monitoring, cardiovascular health and patient education. He works with medical reviewers, product specialists and internal experts to help make articles clear, accurate and useful for readers.
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  1. 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.
  2. Hilo Bracelet G1 has been CE-marked under the Medical Device Regulation (EU)2017/745 as a class IIa medical device.
  3. 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.
  4. 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.
  5. 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.
  6. 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.