AliveCor Receives CE Mark For Atrial Fibrillation Algorithm

AliveCor Receives CE Mark For Atrial Fibrillation Algorithm

shutterstock_167852012AliveCor, Inc. recently announced that it received Conformite Europeenne (CE) Mark clearance for the company’s algorithm for an automated analysis process to detect atrial fibrillation (AF), the most frequent heart rhythm problem and number-one cause of stroke. AliveCor’s latest version of AliveECG for UK and Ireland users provides patients with real-time AF detection in electrocardiogram (ECG) recordings using the AliveCor® Heart Monitor. This new AF Detector has the capacity to analyze each ECG registered and notify the user automatically if that specific ECG represents a reason why someone needs to be concerned about their heart health or with their beloved ones.

The CE Mark is significant in that it allows the AliveCor Heart Monitor and the AliveECG app with the AF detector (and respective algorithms) to be used in other countries in Europe that require the clearance. The AliveCor AF Detector represents a major step towards mobile health monitoring, which will allow patients to contact their physicians immediately when something is not right with their heart rhythm.

The AliveECG app is currently free and includes features that are quite easy to use and personalize, and are extremely useful to track medication, ongoing symptoms, and lifestyle choices.

Richard Bogle from the St. Helier Hospital commented in the press release: “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. 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. Receiving CE Mark is a tremendous achievement that will allow expanded access to the AliveCor Heart Monitor. 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,” added Euan Thomson, CEO and president at AliveCor.

About a third of those with AF are still undiagnosed, which emphasizes the need for early detection and screening. With the appropriate treatment, 3 or 4 AF-related strokes can be prevented and lives can be saved. The AliveCor Heart Monitor can be used in iOS and Android OS mobile devices and patients can securely access their data anytime.

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