MindChild Medical announced that it has received ISO 13485:2003 certification for the design, development and manufacturing of its MERIDIAN family of non-invasive fetal monitors. ISO 13485:2003 certification precedes European pre-marketing submission of a Technical File submission, enabling European commercialization of the MERIDAN family of fetal monitors. MindChild previously announced 510(k) pre-marketing 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‐marketing clearance of the current 510(k) notification. Additional pre‐market regulatory filings are anticipated during 2016.
The MindChild Medical Meridian M110 fetal 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 Meridian M100 and M110 fetal heart monitors are intended to be compatible with qualified 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 more than 36 completed weeks, in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.