IntriCon Sirona CDM wins FDA 510(k) approval

The US Food and Drug Administration (FDA) has granted 510(k) marketing approval to IntriCon's second-generation Sirona cardiac diagnostic monitor (CDM).

The new Sirona CDM aids physicians to monitor patient cardiac events remotely.

With IntriCon’s PhysioLink wireless technolog, Sirona CDM device combines event and holter recording.

For a distance of up to five meters, PhysioLink enables audio and data streaming to body-worn and ear-worn applications.

IntriCon president and CEO Mark Gorder said Sirona shifts patient care from expensive health-care settings to the home, thus not only reducing costs but also improving patient comfort.