MindChild Medical received 510(k) clearance from the U.S. FDA for a new fetal heart monitor the company says can detect tiny fluctuations in fetal heartbeats and potentially reduce the number of Caesarean sections pregnant women undergo.
Company officials said the regulatory win clears the way for the company to commercialize its Meridian non-invasive fetal heart monitor.
“We are thrilled to have reached this milestone,” CEO Bill Edelman said in prepared remarks. “Meridian is the 1st in a series of non-invasive fetal monitor technologies developed by MindChild that are intended to provide the healthcare community enhanced monitoring capabilities for both fetal heart rate and fetal ECG. We anticipate significant clinical interest for this innovative technology in the markets where Meridian will be cleared for commercial distribution.”
The North Andover, Mass.-based startup was founded in 2008 a collaboration between Tufts Medical Center, MIT and E-Trolz Inc.
In a 2009 interview with MassDevice.com, MindChild vice president Jay Ward told us the technology for Meridian stemmed from a collaboration between Dr. Adam Wolfberg, a Tufts Medical Center fellow, and a prominent MIT researcher.
Wolfberg, looking to create a more precise fetal heart monitor, wasn’t getting the results he wanted so he enlisted MIT Researcher Gari Clifford, who had been working with E-Trolz on the company’s signal acquisition technology. When he met Wolfberg, it occurred to him that E-Trolz and the physician should be working together.
Using their combined expertise they went to work developing a heart monitor that could separate the signals from the heartbeat of a fetus from its mother’s. As Ward described it to us, E-Trolz provided the ability to acquire the 2 signals and Clifford helped develop the ability to parse and analyze them.
There are only 2 ways to listen to a fetal heartbeat, he explained – ultrasound or a fetal scalp electrode. Although ultrasound is the most common and non-invasive practice, it’s not accurate enough to distinguish between small variations in the unborn child’s heartbeat because it only listens for blood flow and the movements of the fetus require the physician to constantly readjust the device.
The 2nd method, a fetal scalp electrode, can only be applied when the mother is fully dilated during labor.
Ward said the new, non-invasive technology is even more accurate than a fetal scalp electrode because it provides a 3-dimensional picture of the health of the baby’s heart.
Clifford described the technology as "like going from a 1-dimensional slice of an image to a hologram" in a March 2009 article for MIT’s Innovations Report.
The ability to listen more closely and more accurately to fetal heartbeats could have a big impact on the amount of C-section births performed every year, Ward added. "You get a lot of false positives [with current fetal monitoring], so [physicians] do a C-section to be on the safe side," he explained.