Aktiia wins race for approval of heart wearable

Swiss startup Aktiia has beaten Fitbit, Apple and other HealthTech players to become the first firm to get regulatory approval to sell a wearable bracelet that automatically measures blood pressure 24/7.

The firm has won a CE Class IIa medical device mark for its bracelet, which allows it to sell its technology across the European Economic Area, the UK, Australia and Canada. But it's entering the UK market first, as it is seen as the most lucrative for this type of technology in Europe.

Aktiia’s clinically validated Optical Blood Pressure Monitoring technology estimates blood pressure day and night “accurately, automatically and painlessly”, said the vendor, by analysing signals from the wearer’s wrist.

The data is then visualised in a free companion application, and with a click a digital summary can be easily shared with a physician or family member.

“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,” said Aktiia.

“Hypertension is the number one 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,” said Poulter.

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.

The core technology was first developed at the Swiss Center for Electronics and Microtechnology (CSEM), and Aktiia was founded as a spin-off in 2018.

Aktiia is now available to pre-order in the UK, with a limited time promotional price of £159 including VAT, shipping, the mobile app for iOS and Android and an initialisation cuff.

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