Aktiia, the Swiss start-up 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 ground-breaking 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. Today’s announcement represents a significant advancement in BP data collection and hypertension management, enabling the development of optical systems that do not require any calibration while meeting the stringent BP performance thresholds for regulatory approval. The healthcare industry is already taking note: “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.
Transforming Wearables and Smartphones into Medical-Grade Devices
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, smart bands, 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 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 and Co-founder of Aktiia.
Read the article online with PharmaPhorum