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.
Cardiac Insight claims that use of the device can improve the time it takes to diagnose and treat cardiac disorders, reduce healthcare costs and improve patient conditions. Physicians using the device can access full-disclosure cardiac data for immediate review, the company said, without a 3rd-party service.
The Cardea Solo is designed to be worn under lcothing for up to 7 days, and can be worn during normal daily activities.
Last April, Cardiac Insight said it closed a $2.5 million Series C funding round to support its CardeaScreen device and finalize development of its Cardea Solo.
The CardeaScreen is a handheld 12-lead electrocardiogram device and software that Cardiac Insight says “provides a major breakthrough” in improving quality and reliability of ECGs to identify issues associated with sudden cardiac arrest in young athletes.