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FDA clears single device for simultaneously taking ECG and measuring BP

FDA clears single device for simultaneously taking ECG and measuring BP

The U.S. Food and Drug Administration, FDA has cleared first blood pressure monitor with ECG capability in a single device. The device known as Complete is an upper arm blood pressure monitor that allows users to simultaneously monitor ECG and blood pressure readings at home.

Omron Healthcare, Inc., has secured FDA clearance on its new Complete™, the first blood pressure monitor with EKG capability in a single device, and Proposes to open pre-orders on April 15th at 12:00 pm CST in the U.S.

In the new device, EKG readings can be measured by touching electrodes conveniently located on the top face and both sides of the monitor for easy access and comfort. EKG is an essential measurement for those with atrial fibrillation, also known as arrhythmia or Afib, a condition causing an irregular heartbeat that can lead to heart health-related complications, including increased risk of stroke and heart failure.

“Millions of Americans are living with Afib and a stroke risk that is five times higher than average, and many others may not know they have this condition since it is difficult to diagnose. Recent studies predict that the number of individuals with Afib could reach epidemic levels as a result of the growing aging Baby Boomer population. Monitoring this condition and the risk it carries is part of our Going for Zero mission. That’s why Omron developed Complete as an accessible, easy-to-use, at-home solution to provide a more complete heart health picture and greater peace of mind,” said Ranndy Kellogg, president & CEO of Omron Healthcare, Inc.

“Irregular heartbeat is unpredictable and can be difficult to detect without regular monitoring. The Omron Complete empowers anyone who suspects they might have arrythmia or has family history of the condition to monitor their status easily at home,” said Kellogg.

Complete is the recent recipient of the iF Design Award 2019, presented by iF International Forum Design GmbH, one of the world’s most prestigious design awards. This award was presented to Complete for its uniqueness, innovation, aesthetic appearance and performance.

Complete will be available for $199.99 (USD) pre-order only in the U.S. on, with retail availability expanding to Amazon beginning May 1, 2019.

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  1. Awesome product and good article