We’ve covered several wearables that use photoplethysmography (PPG) technology for monitoring hypertension, most recently Biobeat’s 24BP Kit. PPG devices emit light at different wavelengths and employ optical sensors to gather biometric data. This can include changes in arterial blood flow volume based on variations in reflected light intensity.
The Aktiia Bracelet is a PPG-based continuous blood pressure monitoring wrist-band device, At CES 2022, Aktiia announced that the device will be tested in a study at the Brigham and Women’s Hospital (BWH) as part of the hospital’s Remote Hypertension Program. The sub-study is called COOL-BP (Continual vs. Occasional Long-Term BP).
We wrote about Aktiia’s search for effective optical continuous blood pressure monitoring in 2018. Two validation studies published in peer-reviewed journals in 2021 explored the effectiveness of the Aktiia Bracelet. A study in Scientific Reports in October 2021 compared the PPG bracelet to standard auscultatory measurements in different body positions. An August 2021 article published in Blood Pressure Monitoring reported on the accuracy of a cuff-less wrist device in a 1-month continuous monitoring study.
The Aktiia Bracelet wrist wearable is currently available for purchase with CE Mark Class 2 clearance in the UK, Switzerland, Germany, Austria, France, Ireland, and Italy. It is worth noting that the wearable is contraindicated for patients in Europe with atrial fibrillation. Aktiia has applied for FDA authorization to market the device commercially in the US, though currently, Aktiia only has an Investigational Device Exception in the US, solely for inclusion in clinical investigations such as the BWH study.
The field of cuff-less blood pressure monitoring is advancing rapidly. According to the CDC, more than half a million deaths in 2019 in the US had hypertension as a primary or contributing cause. If convenient wearables could help more people bring their hypertension under control, we could save thousands of lives every year.
Pivotal study lacking ISO81060-2 criteria for reference SBP distribution >140mmHg