IntriCon’s cardiac monitoring tool wins FDA clearance

A Minnesota public company that makes miniature body-worn devices announced Thursday that the U.S. Food and Drug Administration has cleared its wireless cardiac diagnostic monitoring (CDM) device.

IntriCon said that its Centauri Ambulatory Patient ECG device can remotely monitor patients who experience symptoms on and off that put them at risk of developing cardiac arrhythmia. The device can automatically detect arrhythmia and can wirelessly transmit the data to a doctor.

“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,” said Mark Gorder, IntriCon’s president and CEO, in a news release.

Based on previous quarterly conference calls, it appears that IntriCon had expected FDA clearance this year, despite the uncertainty that has plagued the 510(k) device review process. The company plans to launch the Centauri in the third quarter and expects to get “modest revenue contributions” from the newly cleared device in the fourth quarter.

In the second quarter ended June 30, IntriCon’s revenue fell $1 million to $13.9 million. The company suffered a loss of $294,000, or 5 cents per diluted share, compared with a profit of $269,000 or 5 cents per diluted share.

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