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MindChild files FDA application for fetal heart monitor

MindChild Medical Inc., a North Andover medical device company, said it has completed the filing of a Pre-Marketing Notification Application with the Food and Drug Administration for a non-invasive fetal heart monitor.

In a press release, the company said it expects feedback from the FDA during the next quarter and anticipates entering the US market with its Meridian fetal heart monitor following FDA pre-market clearance.

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Last year, there were about 4.1 million births in the United States, and 85 percent of them required fetal monitoring during labor and delivery, MindChild Medical said.

According to the company, its Meridian product candidate is safer and more effective than fetal heart monitors currently on the market.

Chris Reidy can be reached at reidy@globe.com.
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