Aktiia has announced that its automated blood pressure monitoring system has received the CE mark as a Class IIa medical device. With the CE Mark, Aktiia now has access to over 40 countries worldwide.
Aktiia says that the device 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 visualised in a free companion application, through which a digital summary can be easily shared with a physician or family member.
The core technology was first developed at the Swiss Center for Electronics and Microtechnology (CSEM), Neuchâtel, Switzerland. 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), Lausanne, Switzerland, 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 journal Blood Pressure Monitoring.
“Hypertension is the number one cause of cardiovascular disease and premature death worldwide,” said Neil Poulter, professor of Preventive Cardiovascular Medicine at Imperial College London, London, UK. “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.”
Aktiia’s Optical Blood Pressure Monitoring (OBPM) algorithms leverage optical sensors worn on the wrist and provide blood pressure values using photoplethysmography (PPG) to analyse 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.
“With cardiovascular disease as the leading cause of death across the world, people need to better understand the impact of their lifestyle choices and physicians need the ability to more deeply understand blood pressure patterns so they can change the way that they diagnose and treat people living with hypertension,” said Mike Kisch, Aktiia CEO. “After 15 years in development and one million blood pressure readings, Aktiia has cracked the code to bring to market the world’s first automated 24-7 blood pressure monitoring system.”