Making labor safer for

               women and their babies

Meridian Cleared
by FDA for
US Market

Meridian Monitor

Electrocardiogram (ECG) monitoring has been
widely used on adult patients for decades. In adults,
signals representing a patient’s cardiac activities are
collected through a set of skin surface electrodes
distributed over the patient’s body.

Monitoring of fetal ECG (fECG) in this manner, however,
can be difficult due to the co-existence of maternal and
fetal signals acquired from a patient, as well as the relatively low fetal signal level relative to the maternal signal and other noise sources. MindChild has developed the MERIDIAN Fetal Heart Rate Monitor which is a device that utilizes external electrodes and a proprietary algorithm to discern between fetal and maternal signals allowing for an external, non-invasive device to calculate the fetal heart rate.

The MERIDIAN Monitor is a hospital or patient room device that consists of a ready roll-up cart with the associated connectors and display that allow for the accurate recording and display of the maternal and fetal heart rates.

21 CFR §801.109: “Caution: US Federal Law restricts this device to sale by or on the order of a physician”

 

About the Fetal Heart Monitoring Market

Over 85% of the 4,000,000 live births occurring in the US during 2011 required fetal monitoring during labor and delivery. Current non-invasive Doppler, employing ultrasound to detect FHR, is subject to loss of fetal heart rate due to maternal/fetal movement. Fetal Scalp Electrodes (FSE) that connect directly to the fetus during the later stages of labor and delivery are associated with increased risk of maternal/fetal infection. There are an estimated 28,000 fetal monitors spread over 3,400 hospitals in the US, representing an investment of over $700,000,000. MERIDIAN has been developed to provide uninterruptible fECG data while addressing the deficiencies in both Doppler and FSE via innovative non-invasive monitoring technology.

 

“ACOG Refines Fetal Heart Rate Monitoring Guidelines”, 6/22/2009 The American College of
Obstetricians and Gynecologists Press Release
http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_03.pdf

Journal of Midwifery. Vol 18, No, 7: 424-428. July 2010
American Family Physician, 1992 Feb;45(2):579-82
http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html

Company estimates.

 

 

Indications for Use

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/activity (UA). The Meridian M110 Fetal Monitoring System acquires and displays the FHR and UA from abdominal surface electrodes that detect the fetal ECG signal, maternal ECG signal, and uterine muscle contraction signal. 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 healthcare professionals in a clinical setting.

 

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Meridian 110

Meridian M110

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