The US Food and Drug Administration (FDA) has given 510(k) marketing clearance to IntriCon for its Centauri ambulatory patient electrocardiogram (ECG), a wireless cardiac diagnostic monitoring (CDM) device. The Centauri combines event recording with wireless transmission of patient data allowing physicians to continuously monitor patient cardiac events remotely.
“With rising health care costs, we are excited to offer a device that will not only improve patient quality of life, but also reduce treatment costs by providing the ability to identify asymptomatic cardiac events remotely. The Centauri follows current industry trends of shifting patient care from expensive health-care settings to the home which not only reduces costs but improves patient comfort,” said Mark S Gorder, president and CEO at IntriCon.
The Centauri device provides diagnostic evaluation of patients who experience transient symptoms that may suggest cardiac arrhythmia. With continuous monitoring, automatic arrhythmia detection and wireless transmission of the recorded cardiac activity to a licensed physician for review.
Given the timing of the FDA clearance, IntriCon expects to release the product in the third quarter of 2011 and anticipates modest revenue contributions in the 2011 fourth quarter.