FDA approves wearable ECG sensor

The U.S. Food and Drug Administration (FDA) has approved Cardiac Insight’s wearable electrocardiogram sensor, a device that provides physicians with immediate access to improved reporting and analysis of heartbeat data.

The sensor, branded the Cardea Solo, can diagnose arrhythmias by recording data from the patient wearing it, according to an April 20 press release from the Kirkland, Washington-based company.

The sensor collects ECG data and patient symptoms while software analyzes the data to predict and detect any heart problems. It also eliminates the need for outsourcing to costly and time-consuming third-party service centers by putting the patient in control of the data. It’s small, lead-less and water-resistant, making it easy to wear all the time.

“Cardea Solo is an affordable, patient friendly and nonintrusive device designed to improve health care for the millions of patients who suffer from arrhythmia,” said Brad Harlow, co-founder and CEO of Cardiac Insight, in a statement “The timely retrieval of cardiac patient data can contribute to improved diagnosis and treatment and lower health care costs.”