AliveCor receives CE Mark clearance for algorithm to detect atrial fibrillation

AliveCor, Inc. announced today it has received CE Mark clearance for its automated analysis process (algorithm) to detect atrial fibrillation (AF), the most common heart rhythm disturbance and a leading cause of stroke. The latest version of the AliveECG app for users in the United Kingdom and Ireland now provides patients with real-time AF detection in electrocardiogram (ECG) recordings using the AliveCor® Heart Monitor. The new AF Detector analyses each ECG recorded and automatically notifies the user if AF is detected in that ECG, a step forward for anyone concerned with their own heart health or that of their family members.

Atrial fibrillation continues to be the most common heart rhythm disturbance, affecting about 2 million people in the UK and Ireland, and is responsible for a third of all strokes. AF and AF-related illness costs the National Health Service over £2.2 billion annually – a cost that is expected to rise as the incidence of AF accelerates. AF can be hard to detect, as symptoms, including heart palpitations, may be mild or non-existent. The new AliveCor AF Detector represents a major step in the advancement of mobile health, allowing patients to instantly know if AF is present in their ECG, and immediately take action as recommended by their physician.

AliveCor remains focused on helping those with diagnosed and undiagnosed heart conditions determine what may be impacting their heart health. The new AliveECG app, currently free to customers, also includes features that help patients and physicians manage existing conditions with intelligent, personalized and easy-to-use new features. Tracking of medications, lifestyle choices and ongoing symptoms allows patients to have a better understanding of their health status. Advanced search features and enhanced graphical trends provide a more comprehensive and reliable view of a person's overall health*.

"The new AF Detector, along with the tracking of medications and lifestyle factors will make it easier for me to identify and manage serious heart arrhythmias in my patients," said Richard Bogle, FACC, Consultant Cardiologist, St. Helier Hospital. "My patients will significantly benefit from being able to find out if they are having an AF episode and together it will allow us to determine which medications, habits and activities may be impacting their heart. With a more complete view of what is happening with my patients, even between appointments, we can make better decisions."

"The UK and Ireland make up more than 20% of our customers and we are excited to now be able to share the AF Detector with them as a powerful tool to help manage their heart conditions," said Euan Thomson, president and chief executive officer at AliveCor. "The AF Detector, and our continued efforts to support the local community with screening for AF, reconfirm our goal of providing patients and caregivers with clinical-quality, mobile health technology and analysis that can improve heart health."

Since June 2014, AliveCor has helped screen thousands of people for AF at local pharmacies in the UK and Ireland. Working with prominent pharmacies and government entities, in association with the Atrial Fibrillation Association (AFA) AliveCor has developed a cost-effective community screening programme. Nearly a third of people who have AF are not yet diagnosed, elevating the importance of early detection through screening. With treatment, three out of four strokes related to AF can be prevented, potentially saving lives and reducing the community burden of stroke.

The AliveCor Heart Monitor is intended to record, store and transfer single-channel ECG rhythms. The AliveCor Heart Monitor also displays ECG rhythms and detects the presence of atrial fibrillation. The AliveCor Heart Monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The AliveCor Heart Monitor is compatible with all iOS and most Android OS mobile devices. With secure storage in the cloud, users have the ability to access their data confidentially anytime, anywhere.

Source:

AliveCor, Inc.

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