IntriCon, a developer of miniature and micro-miniature body-worn devices, has received the US Food and Drug Administration (FDA) 510(k) approval for Centauri Ambulatory Patient ECG, its first-generation wireless cardiac diagnostic monitoring (CDM) device.
The CDM device wirelessly transmits patient data and combines event recording which aids physicians to continuously monitor patient cardiac events remotely.
The CDM device offers diagnostic evaluation of patients with symptoms of cardiac arrhythmia and its recorded cardiac activity is viewed by a licensed physician.
IntriCon president and CEO Mark Gorder said they 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.