What sets Aktiia apart from other cuffless blood pressure monitors in development? One of the major challenges for other products announced publicly to date is that they only work when the user places their arm at heart level and manually pushes a button to trigger a measurement while at rest. The Aktiia bracelet is an automated cuffless solution, with measurements triggered by the device around the clock, without interrupting daily life.
To ensure that measurements can be taken accurately in the background without requiring a specific body or arm position, the Aktiia team implemented a very technically challenging clinical validation protocol. In a peer-reviewed paper accepted for presentation at the 2020 IEEE Engineering in Medicine and Biology Conference (EMBC), Aktiia discloses the details of this trial design, and results from a pilot study with the Aktiia bracelet.
The Aktiia Bracelet and App (left) and examples of positions tested (right).
Using this protocol, the Aktiia bracelet and algorithms were able to generate accurate blood pressure estimates in multiple positions: while the user was lying down (~67% of the time), sitting (~50% of the time), and standing (~25% of the time). Prior to any measurements being displayed in the Aktiia app, all unsuccessful measurement attempts are discarded, allowing for 24/7 measurements that the user and their doctor can trust.
Since this initial pilot trial, Aktiia has further implemented this protocol in a pivotal trial across a larger, more diverse subject population. Pending FDA clearance and CE mark, Aktiia’s product will become the first automated cuffless solution able to measure accurately in the background of daily life without hassle, regardless of body position.