Business

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.

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.

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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.