FDA Clears MindChild Medical’s MERIDIAN M110 Fetal Monitoring System

MindChild Medical, Inc. today announced that it has received clearance for its Pre-Marketing Notification (510(k)) from the US Food and Drug Administration (FDA) for its MERIDIAN M110 non-invasive fetal heart monitor. MindChild anticipates entering the US market with MERIDIAN now that it has received the FDA clearance.
 
The MERIDIAN M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The MERIDIAN M110 Fetal Monitoring System acquires and displays FHR, MHR and UA from abdominal surface electrodes that detect the fetal ECG signals, maternal ECG signals, and of uterine muscle contraction signals. Tracings of FHR and UA are displayed onto a primary fetal monitor.
 
The MERIDIAN M110 Fetal Monitoring System is indicated for use on women who are at ≥ 37 completed weeks, in labor, with singleton pregnancies using surface electrodes on the maternal abdomen. The MERIDIAN M110 Fetal Monitoring System is intended for use by health care professionals in a clinical setting.
 
“We are thrilled to have reached this milestone,” stated Bill Edelman, CEO. He continued, “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.”
 
Adam Wolfberg, M.D., chief medical officer for MindChild stated, “This FDA pre-market clearance delivers a highly-reliable fetal monitor to the obstetric community. 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.”