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FDA clears Omron BP/EKG monitor

April 16, 2019 By Danielle Kirsh

omron-complete-system

[Image from Omron Healthcare]

Omron Healthcare recently announced that it has received FDA clearance for its Complete blood pressure monitor with EKG capabilities.

The Complete system is an upper arm blood pressure monitor that allows users to monitor both EKG and blood pressure readings from home. EKG readings are measured by touching electrodes that are located on the top and sides of the monitor. EKG measurements are important for people who have atrial fibrillation, which causes an irregular heartbeat.

“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,” Ranndy Kellogg, president and CEO of Omron Healthcare, said in a press release. “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.”

Omron developed the Complete system with AliveCor, which is a company developing personal EKG technology. The Complete system uses an advanced new algorithm developed by AliveCor to improve Afib detection with medical-grade blood pressure measurement from Omron.

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

Complete is now available for purchase in the U.S. through the Omron Healthcare website.

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  • Home
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