IntriCon Receives FDA 510(k) Marketing Clearance for Centauri Cardiac Diagnostic Monitor

IntriCon Corporation IIN today announced it has received 510k marketing clearance from the U.S. Food and Drug Administration (FDA), for the Centauri Ambulatory Patient ECG, its first-generation wireless cardiac diagnostic monitoring device. The Centauri combines event recording with wireless transmission of patient data allowing physicians to continuously monitor patient cardiac events remotely. Mark S. Gorder, president and chief executive officer at IntriCon said, “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.”