Aktiia receives regulatory approval

Aktiia, the Swiss startup revolutionizing Blood Pressure (BP) monitoring and management, announces it has received regulatory approval (CE mark) for its next-generation optical technology that does not require calibration with a traditional cuff.

The CE mark allows market access to potentially over 40 countries. The underlying groundbreaking calibration-free technology, known as CALFREE™, 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 CALFREE technology into various third-party devices.

Since its inception in 2018, Aktiia has been an innovative pioneer of blood pressure technology, known for its scientific rigor, visionary team, and initial breakthrough product – the first continuous BP monitoring device worn on the wrist, which currently requires monthly calibration.

“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 growing exponentially, with over 10 billion signals from more than 70,000 users worldwide, creating countless opportunities for discoveries that advance our collective understanding of blood pressure and provide predictive insights on a global scale.

This extensive dataset has enabled Aktiia to create unprecedented Foundation Models of blood pressure, previously unattainable without the size and richness of this extensive dataset.

Source: press release