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Medical Devices / Submissions and Approvals

FDA Grants Marketing Clearance to Cardiac Insight’s Wearable ECG Sensor

April 24, 2017

Washington–based Cardiac Insight has gained FDA marketing clearance for its Cardea Solo wearable electrocardiogram sensor.

The Cardea Solo is used to assist in the diagnosis of a variety of arrhythmias by recording ECG data and patient symptoms.

The device weighs about 25 grams and is lead-less, water-resistant and single-use disposable. It is designed to encourage better patient compliance for recording of data. — Cynthia Jessup

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