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Cardiac Insight Announces FDA Clearance of “CARDEA SOLO™” – The First Wearable (ECG) Sensor Giving Physicians Immediate Access to Complete Cardiac Arrhythmia Data and Analysis

Cardiac Insight, a U.S. developer of body worn sensing devices and computational software, announced today, the FDA has cleared the company’s wearable electrocardiogram (ECG) sensor, CARDEA SOLO™. The device offers physicians immediate access to improved reporting and analysis of heartbeat-to-heartbeat data. The design and ease of use also encourage better patient compliance for the acquisition and recording of complete patient data. CARDEA SOLO will be used to assist with the diagnosis of a variety of arrhythmias, including the most common, atrial fibrillation (AFib).

The company expects the capabilities of CARDEA SOLO to enhance efficiencies in mean time to cardiac diagnosis and treatment, which can contribute to improved conditions for patients and reduce health care system costs.

“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 Chief Executive Officer of Cardiac Insight, Inc. “The timely retrieval of cardiac patient data can contribute to improved diagnosis and treatment and lower health care costs.”

Physicians can now use CARDEA SOLO in their offices to retrieve full-disclosure cardiac data for immediate review and action - a process that previously required days or weeks. For the first time, the sensor technology eliminates the need for outsourcing to costly and time-consuming third-party service centers and puts control of the patient data, analysis and processing in the hands of physicians and their staff. Global service billing is streamlined and the need to track and reprocess in-house capital equipment is eliminated.

The device is small, lightweight (approximately 25 grams), lead-less, water-resistant and single-use disposable. Patients can wear CARDEA SOLO comfortably under their clothing for up to seven days and maintain their normal daily activities.

The CARDEA SOLO sensor records ECG data and patient symptoms. The physician office software analyzes the recorded cardiac data to provide physicians with full-disclosure of all data, ECG trace review tools and a summary report of heart rhythms.

The American Heart Association journal, Circulation, reported that 33.5 million people around the globe have AFib. According to the National Stroke Association, AFib raises a person's risk for stroke by 500 percent and most AFib-related strokes can be prevented.

CARDEA SOLO is available by contacting [email protected].

About Cardiac Insight:

Cardiac Insight, Inc. (www.cardiacinsightinc.com) is a U.S. developer of advanced body-worn digital health care information devices for cardiology, respiratory and other complex disease states. The company’s technologies and systems are created using advanced algorithms and software that provide improvements in mean time to diagnosis. Cardiac Insight’s mission is to invent complete and progressive solutions for unmet clinical needs on behalf of physicians, clients and payers. Cardiac Insight was founded in 2008 and is based in Kirkland, WA.

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