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Medical Devices / Submissions and Approvals

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

April 24, 2017
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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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