Swiss startup Aktiia has received the CE mark approval in Europe for CALFREE, its next-generation, calibration-free optical blood pressure (BP) technology.

CALFREE is said to be the world’s first BP data collection and hypertension management system that does not need calibration with a traditional cuff.

The technology utilises input from optical sensors typically found in smartwatches or the cameras of commercial smartphones.

It offers an accessible, comfortable, and convenient approach to long-term BP monitoring. This is expected to improve BP management and reduce the economic and health burdens associated with hypertension.

Aktiia said that the latest regulatory clearance will help integrate CALFREE into various third-party devices.

CALFREE will be integrated into a wide range of consumer devices like smartwatches, smartbands, and smartphone cameras.

In addition, the CE mark will allow the startup to market the medical-grade blood pressure system in potentially over 40 countries.

Aktiia co-founder and chief technology officer Josep Sola said: “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.”

Founded in 2018, the Swiss firm focuses on BP monitoring and management. Its initial breakthrough product was a BP monitoring device worn on the wrist which requires monthly calibration.

Aktiia’s blood pressure dataset has now more than 10 billion signals sourced from more than 70,000 users across the globe.

The data is expected to support the collective understanding of blood pressure and offer predictive insights on a global level.

Leveraging this dataset, the BP management firm has created Foundation Models of blood pressure.

The inaugural product of the company, Aktiia G1, secured CE-marking in December 2020. Aktiia G1 provides continuous blood pressure monitoring with monthly calibrations.

In February this year, the company raised $30m in funding to accelerate innovation in hypertension management.