Devices & Diagnostics

CardioInsight CEO out, replaced by two-person ‘office of the president’

Noninvasive cardiac mapping company CardioInsight Technologies said its CEO and Chairman Steve Arless is stepping […]

Noninvasive cardiac mapping company CardioInsight Technologies said its CEO and Chairman Steve Arless is stepping down.

No reason was given for Arless’ departure in a statement from the Cleveland-based company, which is fresh off a $7.5 million series C investment.

“The board of directors expresses its appreciation for Mr. Arless’ service to the company during his tenure,” the statement said.

Managing CardioInsight’s day-to-day leadership responsibilities will fall to a two-person “office of the president,” which will consist of Charu Ramanathan, co-founder and chief scientific officer, and Kevin Mendelsohn, vice president of finance and corporate development. Ramanathan didn’t immediately return a call.

Jim Bullock will step into Arless’ former role as chairman, and he brings experience engineering two exits. Bullock was previously CEO of Atritech, an electrophysiology company that was acquired by Boston Scientific in 2011, and Endocardial Solutions, a catheter-based cardiac mapping company that was acquired by St. Jude Medical in 2005.

“The company is well positioned, and Charu and Kevin are prepared to lead the company through this next phase in its development,” Bullock said in the statement.

It’s unclear whether Arless’ departure was unexpected, or had been planned for a while. CardioInsight is in some regard entering its next phase, as Bullock noted, in that it’s beginning to commercialize its cardiac mapping device in Europe, so it’s possible that Arless took the company as far as he’d intended to.

The company last year received European regulatory approval for the device and is in discussions with the U.S. Food and Drug Administration aimed at planning a regulatory pathway for the company’s ECVUE electrocardiographic mapping system, which gathers electrical information about the heart from an electrode vest placed on a patient’s body and combines that information with images from a CT scan to produce 3-D maps of the electrical activity of the heart.

Unlike conventional methods, CardioInsight’s technology is noninvasive and provides beat-by-beat, whole-heart mapping. The technology — a sensor array on a vest and software to collect, analyze and combine its data with the CT image — is used to help diagnose and treat electrical abnormalities of the heart, such as those associated with arrhythmia and heart failure.

Arless said last month it was likely that the FDA would require a clinical study of the device prior to awarding a 510(k) clearance.

 

 

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