MindChild Medical seeks FDA nod for fetal heart monitor

By Michelle Lang

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North Andover startup MindChild Medical Inc. has filed a 510(k) pre-market notification application with the U.S. Food and Drug Administration for its Meridian non-invasive fetal heart monitor.

The monitor is designed to measure the health of unborn babies and ensure safe deliveries.

The company said in a news release that it expects the FDA to provide feedback on the 510(k) application in the next quarter, and it plans to begin marketing Meridian, based on expected approval, once it receives FDA clearance.

MindChild Medical was co-founded in 2008 by Tufts Medical Center’s Adam Wolfberg; MIT and Harvard University researcher Gari Clifford; and E-trolZ co-founders Jay Ward and Jim Robertson. In their current positions with MindChild, Wolfberg serves as chief medical officer, Clifford is chief technology officer, Ward serves as executive vice president, and Robertson works as chief operating officer.

The company, which was named a Mass High Tech “Startup Watch: Five to follow” company in 2010, raised $373,594 of a planned $500,000 funding, per federal documents filed in May 2011.

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