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Cardea Solo is about 4 inches long, 3 inches wide, and adheres directly to the skin for up to seven days.  (Cardiac Insight Photo)

Consumer wearables, like smart watches and Fitbits, are becoming ever more popular. But wearable medical technology has remained somewhat absent from the scene, despite huge potential for improving patient care and potentially lowering healthcare costs.

Kirkland, Wash.-based Cardiac Insight is hoping to break into that market with Cardea Solo, a lightweight disposable electrocardiogram (ECG) test that monitors a patient’s heartbeat. The company has raised $4.5 million to develop and  commercialize the device and announced today that it has been approved for use by the FDA and is now available to healthcare providers.

The company has raised $4.5 million to develop and  commercialize the device and announced today that it has been approved for use by the FDA and is now available to healthcare providers. Several existing private investors took part in the round.

Cardiac Insight has been developing Cardeo Solo for several years, and it could reportedly cost as little as $20, making it highly accessible to patients.

The Cardea Solo can be used to monitor the cardiac health of patients who have “transient symptoms,” like periodic lightheadedness or chest pains, which cannot be replicated in a doctor’s office, Harlow said

“It’s a very small, disposable monitor,” Harlow said. “A person can wear it for seven days, they can shower with it. It’s worn under the clothing and it’s very light, so you wouldn’t observe it if someone was wearing it.”

The patient would then take the device back to the physician, who can print out a review of the patient’s heartbeat over the time it was worn, Harlow said. The report can help doctors identify irregularities like atrial fibrillation or tachycardia, both of which can be signs of serious heart problems. The device is now available for purchase by care providers.

A wearable ECG test is also produced by the San Francisco-based iRhythm, which went public in October. Unlike Cardiac Insight, iRhythm sells the test as a service instead of a device, acting as a go-between for patients and doctors.

Cardiac Insight was spun out of the University of Washington in 2008 by Harlow and UW cardiologist David Linker. In 2015 the company acquired Cardea Associates and their device, CardeaScreen, which tests for heart problems in young athletes. It was brought to market last year and later rebranded as the Cardea 20/20 ECG. 

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