CE Mark and Launch for AliveCor AF Detection Function

AliveCor, Inc. has received CE Mark clearance for an automated atrial fibrillation (AF) detection function on its AliveCor® Heart Monitor.

Background

Atrial Fibrillation is the most common heart rhythm disturbance and a leading cause of stroke. AF can be hard to detect, as symptoms, including heart palpitations, may be mild or non-existent.

The AliveCor Heart Monitor is intended to record, store and transfer single-channel ECG rhythms and is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals.

 

The newly approved AliveCor AF Detector allows patients to instantly know if AF is present in their ECG, and immediately take action as recommended by their physician.

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. AliveCor says 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. 

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.

Physician comments

“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.”

Company comments

“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.”

Source: PR Newswire

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