MindChild Medical has received the US Food and Drug Administration's (FDA) clearance for its 510(k) pre-marketing notification application (PMA) for non-invasive fetal heart monitor.
The Meridian fetal heart monitor, which measures and displays fetal heart rate (FHR) tracing, is designed for women who are at term (> 36 completed weeks), in labor and with singleton pregnancies.
The company said by using direct ECG (DECG) with a fetal scalp electrode (FSE), FHR can also be measured and displayed.
MindChild Medical CEO Bill Edelman said the non-invasive fetal monitor is intended to provide the healthcare community with enhanced monitoring capabilities for both FHR and fetal ECG.
"We anticipate significant clinical interest for this innovative technology in the markets where MERIDIAN will be cleared for commercial distribution," Edelman added.
Obstetrix Medical Group research and education director Thomas Garite said accurate acquisition of the FHR signal is critical to the safe practice of obstetrics.
"Chronic increases in maternal obesity/Body-Mass-Index have created new challenges for existing non-invasive fetal heart rate monitoring technologies," Garite added.
"This technology cannot help but to improve our ability to make patient decisions."
MindChild Medical chief medical officer Adam Wolfberg said, "In the coming months and years, MindChild will exploit this technology to improve the safety of obstetrics, and hand a new diagnostic device to obstetricians and pediatric cardiologists."