The Food and Drug Administration (FDA) has cleared Cardeo Solo (Cardiac Insight), the first wearable ECG sensor that provides immediate access to patient cardiac data and analysis.

This single-use, lead-less, water-resistant, disposable device can be worn for up to 7 days and weighs only 25 grams. The sensor records ECG data and patient symptoms and through tandem software allows physicians to analyze cardiac data from their office in real-time for immediate review and action.

The technology eliminates the need for outsourcing to third-party service centers and has global service billing streamlined. 

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“The timely retrieval of cardiac patient data can contribute to improved diagnosis and treatment and lower health care costs,” said Brian Harlow, Co-Founder and CEO of Cardiac Insight, Inc.

The company foresees Cardeo Solo being used to assist with the diagnosis of a variety of arrhythmias, including atrial fibrillation, reducing the mean time to diagnosis and treatment. 

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