Cardiac Insight said today it won FDA 510(k) clearance for its Cardea Solo wearable electrocardiogram sensor.
The Cardea Solo device is designed to provide both physicians and patients with cardiac data and help diagnose a variety of arrhythmias including atrial fibrillation, the Kirkland, Wash.-based company said.
“Cardea Solo is an affordable, patient friendly and nonintrusive device designed to improve health care for the millions of patients who suffer from arrhythmia. The timely retrieval of cardiac patient data can contribute to improved diagnosis and treatment and lower health care costs,” co-founder & CEO Brad Harlow said in a press release.
