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MindChild Medical announces filing of 510(k) pre-marketing notification application with FDA for MERIDIAN M110 fetal heart rate monitors

MindChild Medical announced that it has filed a 510(k) pre-market notification with the US Food and Drug Administration (FDA) for its MERIDIAN Model M110 nonā€invasive Fetal Heart Monitor.

MindChild previously announced 510(k) pre-market clearance of the MERIDIAN M100 fetal monitor. MindChild anticipates entering the US market with the MERIDIAN family of fetal monitor products following the FDA pre-market clearance of the current 510(k) notification. Additional pre-market regulatory filings are anticipated during 2016.

The MindChild Medical Meridian M110 Fetal Heart Rate Monitor is an intrapartum fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). The MindChild Meridian acquires and displays the 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 MindChild Meridian M110 is indicated for use on women who are at > 36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The MindChild Meridian is intended for use by health care professionals in a clinical setting.

According to Michael Ross, MD, MPH4, Distinguished Professor of Obstetrics and Gynecology and Public Health, Geffen School of Medicine at UCLA Fielding School of Public Health at UCLA, "The Meridian M110 Fetal Heart Monitor has to potential to consolidate 4 separate fetal and maternal monitoring technologies into one, non-invasive method."

The Meridian M100 and M110 Fetal Heart Monitors5 are intended to be compatible with existing fetal monitoring systems, facilitating rapid adoption by clinicians where MERIDIAN is commercially available. The Meridian M110 and M100 Fetal Heart Monitors are designed for women who are at term (> 36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.

The MindChild Medical Meridian M110 Fetal Heart Rate Monitor is an intrapartum fetal monitor that non-invasively measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA).

The MindChild Meridian acquires and displays the 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 MindChild Medical Meridian M110 Fetal Heart Rate Monitor is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR). The MindChild Meridian M100 acquires and displays the FHR tracing from abdominal surface electrodes that detect the fetal ECG signal (fECG).

FHR tracings are displayed onto a primary fetal monitor. In addition, the M100 synchronizes the TOCO transducer signal which is also displayed to the primary fetal monitor. MERIDIAN M100 is designed for women who are at term (> 36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. MERIDIAN is intended for use by healthcare professionals in a clinical setting.