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By OMAR FORD
Medical Device Daily Staff Writer
MindChild Medical (North Andover, Massachusetts), a med-tech company that was founded in 2008, reported that it has received clearance for its Meridian non-invasive fetal heart monitor. The company said that additional pre-market regulatory filings are anticipated during 2012 and 2013.
Meridian acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG). The company said that Meridian may also be used to measure and display fetal heart rate using direct ECG (DECG) with a Fetal Scalp Electrode.
"The technology was based upon . . . the ability to look noninvasively at the electrocardiographic signal both at a pregnant mother and of the fetus and then to separate them from each other so they could be looked at individually," Bill Edelman, CEO of MindChild told Medical Device Daily. "The Meridian monitor is a device . . . that permits the heart rate of the fetus to be independently and non invasively monitored vs. the mother."
The market for the device could be significant and there are other alternatives out there, but MindChild said none really offer the consistency and convenience of Meridian.
"There are existing technologies out there," Edelman said. "One is called the fetal scalp electrode, which has been around for a number of years. It's basically an electrode line or wire which is attached to the scalp of the fetus while it is still in the mom, and it permits direct connection that can measure the heart rate. But this can only be used during certain periods of the pregnancy. You can't use it all the time. It can only be used during the later stages of the pregnancy when the cervix is dilating and the baby is ready to begin delivery. The other method is called a doppler ultrasound. It's like a disc that's held in place with an elastic belt and rests on the waist."
He added, "The fetal scalp electrode provides a very accurate reading but can only be used part of the time and when you do use it you have to make a connection directly to the fetus' scalp and you have the possibility of increasing infection either to the mom or to the fetus. The doppler ultrasound can be used but depending on the size of the mom, if she's overweight or not, that device can only measure during certain times.
MindChild said this is where the Meridian fetal heart monitor can make the most difference.
"[Meridian], measures on an uninterruptible basis," Edelman said. "It actually provides the same benefit as the ultrasound monitor, but with the continuous high resolution signal that the fetal scalp electrode provides."
The device has the potential to impact a great deal of patients in the U.S. The company pointed out that more than 85%1 of the four million live births occurring in the U.S. during 2011 required fetal monitoring during labor and delivery. There are an estimated 28,000 fetal monitors spread over 3,400 hospitals in the U.S., representing an investment of more than $700 million the company said.
Back in February, the company reported that it had filed for approval of the device.
"We submitted the 510(k) application, results of a trial that we had conducted on a number of moms that was adequate to demonstrate that statistically our measurement method was no worse than the measurement you would find from the fetal scalp electrode, which is the gold standard," Edelman said. "So it's statistically found to be equivalent in terms of the data that's presented by fetal scalp electrodes. We were able to collect fetal scalp electrode data at the same time when we collected this non invasive data, so we had a very nice comparison between the two measurements in the same patients. FDA appreciated that and that's in part how we achieved 510(k) clearance."
MindChild hasn't received the CE mark for Meridian yet, but the firm said that was a goal that it would eventually pursue.
"Our plans . . . are to press forward with multiple additional regulatory clearances and a CE [mark] is definitely part of our thinking," he said.
Omar Ford, 404-262-5546;
omar.ford@ahcmedia.com
Published October 1, 2012
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