AliveCor gets FDA clearance to detect a serious heart condition

AliveCor Heart Monitor

FDA has granted AliveCor clearance for its algorithm to detect atrial fibrillation (AFib), the most common form of cardiac arrhythmia. Said algorithm, or automated analysis process, can detect if patients are experiencing AFib through real-time electrocardiogram (ECG) recordings taken on the mobile phone with AliveCor Heart Monitor, allowing physicians to intervene before potentially life-threatening conditions, like strokes, occur. Through AliveCor’s ECG analysis service, patients can confirm their results with a U.S. board-certified cardiologist or a personal physician.

One in four adults over age 40 develop AFib, making them five times more likely to have a stroke.“The ability to automatically detect serious heart arrhythmia using mobile technology has the potential to save lives, reduce healthcare costs and allow patients and their caregivers to make informed decisions about cardiac care,” said Euan Thomson, president and CEO of AliveCor. “Having achieved clearance, we will work to incorporate the algorithm in our app and plan to make this available to customers during September.”

One in four adults over age 40 develop AFib, making them five times more likely to have a stroke. AFib can be hard to detect, as symptoms may be mild or non-existent. The AFib Detector represents a major step in the advancement of mobile phone based health, allowing patients to instantly know if AFib is present in their ECG.

The AliveCor Heart Monitor is intended to record, store and transfer electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation (when prescribed or used under the care of a physician). It 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 iPhone models and most Android mobile devices.