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Aktiia’s CE Mark approval opens doors to international expansion

Life sciences

17 June 2024

Aktiia has received CE mark approval for its non-cuff optical technology, enabling the start-up to access markets in over 40 countries. Founded in 2018, Aktiia has been at the forefront of blood pressure technology, initially known for its continuous BP monitoring device worn on the wrist. | © Aktiia

Aktiia has received CE mark approval for its non-cuff optical technology, enabling the start-up to access markets in over 40 countries.

Aktiia, the Neuchâtel-based start-up revolutionizing Blood Pressure (BP) monitoring and management, has received regulatory approval for its optical technology that does not require calibration with a traditional cuff. This CE mark allows market access to potentially over 40 countries. The underlying technology uses input from optical sensors commonly found in either smartwatches or the cameras of commercial smartphones. This is a crucial first step towards integrating Aktiia’s technology into various third-party devices.

The healthcare industry has already recognized the potential impact of this innovation. “The ability to monitor blood pressure without using a cuff is a game-changer. This achievement has the potential to greatly improve hypertension care, from better patient motivation to more efficient medication regimens,” said Adrian James, former President of Omada Health.

Aktiia’s blood pressure dataset is expanding rapidly, with over 10 billion signals from more than 70,000 users worldwide. This extensive dataset creates new opportunities for discoveries that advance the understanding of blood pressure and provide predictive insights. It has enabled Aktiia to develop Foundation Models of blood pressure, previously unattainable without such a large and rich dataset.

Revolutionizing blood pressure monitoring for consumer devices

The approval of Aktiia’s CALFREE technology sets the stage for transforming BP monitoring and management by enabling the integration of a medical-grade blood pressure system into a wide range of consumer devices such as smartwatches, smartbands, and smartphone cameras. This will dramatically change 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 realization 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 & Co-founder of Aktiia.

Hypertension remains the leading cause of cardiovascular diseases worldwide. The World Health Organization (WHO) reports that the number of adults with hypertension has doubled from 650 million in 1990 to 1.3 billion in 2019, with projections reaching 1.5 billion by 2025. The current methods of blood pressure monitoring, still reliant on 19th Century technology, involve cumbersome and often inaccurate cuff-based devices.