Aktiia receives CE mark approval for breakthrough 24-7 blood pressure monitoring system

First-ever optical blood pressure monitoring system for 24-7 use now available in the United Kingdom. Aktiia’s clinically validated Optical Blood Pressure Monitoring technology estimates blood pressure accurately, automatically, and painlessly, by analyzing signals from the wearer’s wrist. Aktiia announced the first 24-7, automated blood pressure monitoring system that easily and comfortably gathers data during the day and while sleeping. This groundbreaking medical innovation will now provide people and their physicians comprehensive insights into blood pressure patterns that will better inform the diagnosis and management of hypertension. Now available for sale in the United Kingdom, Aktiia has received its CE Mark as a Class IIa medical device – signifying that the device has been assessed to meet high safety, health and environmental protection requirements in Europe. With the CE Mark, Aktiia now has access to over 40 countries worldwide. See a video of the Aktiia product at this link. Millions of people worldwide are at risk for severe health complications and death due to untreated or uncontrolled hypertension. The average person with hypertension measures their blood pressure only once per week due to the inconvenience and discomfort associated with a traditional cuff. Aktiia is the first product to automatically measure blood pressure over the course of hours, days and weeks without any effort required by the wearer. The data is then visualized in a free companion application, and with a simple click, a digital summary can be easily shared with a physician or family member. The core technology was first developed at the prestigious Swiss Center for Electronics and Microtechnology (CSEM). Aktiia was then founded in 2018 by Dr. Mattia Bertschi and Dr. Josep Sola. Aktiia’s team has some of the world’s scientific and technical experts in optical blood pressure monitoring, including CTO, Dr. Josep Sola, a pioneer in cuffless blood pressure monitoring and editor of “The Handbook of Cuffless Blood Pressure Monitoring. Aktiia has been validated in multiple clinical studies across a diverse population of wearers in multiple body positions. Aktiia’s pivotal clinical trial was conducted at University Hospital Lausanne (CHUV) following international standards of validation and enrolling participants across a representative sample of age, BMI, and skin tone. Its results have been peer reviewed and accepted for imminent publication by the reference journal in the field: “Blood Pressure Monitoring.” “Hypertension is the #1 cause of cardiovascular disease and premature death worldwide,” said Dr. Neil Poulter, Professor of Preventive Cardiovascular Medicine at Imperial College London. “Accurate blood pressure measurement and particularly 24/7 monitoring of blood pressure is increasingly recognised as being important to improve the diagnosis and control of raised blood pressure, thereby improving patient outcomes. Tracking blood pressure over long periods, without alerting the patient represents a potential game changer in the diagnosis and monitoring of hypertension.”

How it works

Aktiia’s Optical Blood Pressure Monitoring (OBPM) algorithms leverage optical sensors worn on the wrist and provide blood pressure values using photoplethysmography (PPG) to analyze the changing diameter of the arteries occurring at each heartbeat. This optical measurement is done automatically, so users are not aware and stressed, and do not have to interrupt their day or their sleep to take a measurement.