MindChild Medical has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its Meridian M110 non-invasive fetal heart monitor.
Meridian M110 is an an intrapartum fetal monitor, which that externally measures and shows fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA).
The fetal monitoring system captures and exhibits FHR, MHR and UA from abdominal surface electrodes that find the fetal ECG signals, maternal ECG signals and uterine muscle contraction signals.
Meridian M110 system is suggested for use on women who are at or above 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen.
According to the company, the Meridian M110 fetal monitoring system is intended for use by health care professionals in a clinical setting.
The company has developed Meridian system to provide uninterruptible fetal ECG data, as well as to solve deficiencies in both Doppler and fetal scalp electrode through an advanced non-invasive monitoring technology.
MindChild Medical CEO Bill Edelman said: “The Meridian M110 Fetal Monitoring System is the latest 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, maternal heart rate and uterine contraction, with a single set of disposable abdominal surface electrodes.
“The Meridian M110 has the potential to provide essential fetal monitoring, replacing four separate monitoring technologies now in use world-wide. We anticipate significant clinical interest for this innovative technology in the markets where Meridian will be cleared for commercial distribution.”