The US Food and Drug Administration (FDA) has cleared a 510(k) pre-marketing notification application of MindChild Medical‘s non-invasive fetal heart monitor.
The Meridian fetal heart monitor, which is designed for women who are at term, measures and displays fetal heart rate (FHR) tracing using the abdominal surface electrodes that detect the fetal ECG signal (fECG).
FHR can also be measured and displayed by using direct ECG with a fetal scalp electrode, according to the company.
MindChild Medical CEO Bill Edelman said the non-invasive fetal monitor is designed to provide the healthcare community with enhanced monitoring capabilities for both FHR and fECG.
"We anticipate significant clinical interest for this innovative technology in the markets where Meridian will be cleared for commercial distribution," Edelman said.
Obstetrix Medical Group research and education director Dr 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 said.
"This technology cannot help but to improve our ability to make patient decisions."
MindChild Medical chief medical officer Dr 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."