MindChild Medical Inc. Announces FDA 510(k) Clearance for MERIDIAN M100 Monitor

(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received clearance for a 510(k)Pre-Marketing Notification Application from the US Food and Drug Administration (FDA) for its MERIDIAN Model M100 non-invasive Fetal Heart Monitor1,2. MindChild anticipates entering the US market with MERIDIAN following the FDA pre-market clearance. Additional pre-market regulatory filings are anticipated during 2015. The Meridian M100 Fetal Heart Monitor3 is intended to be compatible with existing fetal monitoring systems, facilitating rapid adoption by clinicians where MERIDIAN is commercially available. The Meridian M100 Fetal Heart Monitor is designed for women who are at term (> 36 completed weeks), in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen.