MindChild Medical Inc., a medical device company with a new, noninvasive electrocardiograph monitor to report fetal heart rate during labor, has filed a 510(k) pre-marketing notification application with the U.S. Food and Drug Administration that it expects to hear feedback on next quarter.
If all goes well, the company anticipates a product launch following feedback from the FDA.
MindChild’s Meridian technology uses a belt embedded with electrodes that’s wrapped around an expectant mother’s abdomen to monitor subtle changes in a baby’s heartbeat during labor.
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Currently, a baby’s heartbeat is usually measured through a fetal Doppler ultrasound, or by fetal scalp electrodes that are connected directly to the fetus during labor. Ultrasounds, though, aren’t sensitive enough to pick up the smallest changes in a baby’s heartbeat and can also pick up the mother’s heartbeat, leading to unclear results, the company says. And fetal scalp electrodes are associated with increased risk for infection.
MindChild says that the Meridian can reliably separate a mother’s EKG signal from that of the baby and deliver clearer results that can help detect complications, like low-oxygen supply to the fetus, sooner. It also captures a multidimensional look at the heart to help doctors better detect complications.
Most of the 4.1 million live births in the U.S. each year require fetal monitoring. A Lifescience Intelligence market report forecasts the market for products that help monitor and treat neonatal and perinatal patients will grow to $1.5 billion by 2013, but sales growth in the U.S. and Europe are expected to remain relatively flat. There’s also plenty of competition in this area — Monica Healthcare’s beltless, wireless fetal monitor was cleared by the FDA last year, and other devices in development, like the wireless Sense4Baby, measure multiple metrics including blood pressure and blood glucose.
Founded in 2008, MindChild is located in North Andover, Massachusetts. It’s in the middle of raising an $812,000 series A financing.
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