MindChild Medical, Inc. Announces filing of a 510(k) Pre‐Marketing Notification Application with the US Food and Drug Administration for the MERIDIAN™ M110 Line of Non‐ Invasive Fetal Heart Rate Monitors
MERIDIAN M110 Provides Continuous Non‐Invasive Fetal and Maternal
Monitoring Using Surface Electrodes That Detect Fetal ECG (fECG), Fetal
Heart Rate (FHR),
Maternal Heart Rate (MHR), and Uterine Contractions (UA)
NORTH ANDOVER, Mass.–(BUSINESS WIRE)–MindChild Medical, Inc. today announced that it has filed a 510(k)
pre-market notification with the US Food and Drug Administration (FDA)
for its MERIDIAN Model M110 non‐invasive Fetal Heart Monitor1,2,3.
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.” Dr. Ross continued, “There are risks associated with the
invasive methods of fetal heart rate detection and maternal uterine
contraction monitoring. The M110 eliminates those risks. The current
non-invasive technique for fetal heart monitoring is limited by maternal
Body Mass Index (BMI) and the clinical data from the M110 and the
preceding M100 suggest that BMI will not be a limitation in the accurate
monitoring of fetal heart rate. Most critically, both M100 and M110 have
heart rate detection technology which can discriminate between similar
fetal and maternal heart rates, a critical capability which I look
forward to seeing in the clinic.”
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.
About Michael Ross, MD, MPH
Michael Ross is Professor of Obstetrics and Gynecology at the Geffen
School of Medicine at UCLA and a practicing maternal fetal medicine
physician who has extensively studied fetal physiology and fetal
responses to hypoxia. He is the co-author of the textbook Fetal
Monitoring Interpretation, (Lippicott Williams and Wilkins, 2010).
Previous Announcements
On April 19, 2015, MindChild Medical, Inc. announced clearance of a
510(k) Pre‐Marketing Notification Application with the US Food and Drug
Administration for the MERIDIAN™ M100 Line of Non‐Invasive Fetal Heart
Rate Monitors
On November 11, 2014, MindChild Medical, Inc., announced the filing of a
510(k) Pre‐Marketing Notification Application with the US Food and Drug
Administration for the MERIDIAN™ M100 Line of Non‐Invasive Fetal Heart
Rate Monitors
On April 8, 2014, MindChild Medical, Inc., announced the 1,000th
successful non‐invasive fetal heart monitoring session utilizing the
MERIDIAN™ Fetal Heart Monitor
On May 1, 2013, MindChild Medical, Inc., presented the MERIDIAN™
Non‐Invasive Fetal Heart Rate Monitor at the 61st Annual Meeting for the
American College of Obstetricians and Gynecologists (ACOG) in New
Orleans.
On February 13, 2013, MindChild Medical, Inc., presented the MERIDIAN™
Non‐Invasive Fetal Heart Rate Monitor at the 33rd Annual Meeting for the
Society for Maternal Fetal Medicine (SMFM) in San Francisco, CA.
On November 5, 2012, MindChild Medical, Inc., and The University of
Oxford announced a Sponsored Research Agreement for the Development of
Innovative Signal Processing Software for Fetal and Maternal Monitor
with the MERIDIAN™ Non‐Invasive Fetal Heart Rate Monitor.
On September 25, 2012, MindChild announced clearance of a 510(k)
Pre‐Marketing Notification with the US Food and Drug Administration
(FDA) for the MERIDIAN™ M1000 Non‐Invasive Fetal Heart Rate Monitor.
On June 18, 2012, MindChild announced the appointment Thomas Garite,
M.D. to the Clinical Advisory Board for the MERIDIAN Line of
Non‐Invasive Fetal Heart Rate Monitors.
On June 11, 2012, MindChild announced Results of National Fetal
Monitoring Market Survey.
On February 22, 2012, MindChild reported formation of a Clinical
Advisory Board for the MERIDIAN™ Line of Non‐Invasive Fetal Heart Rate
Monitors.
On February 6, 2012, MindChild reported filing of a 510(k) Pre‐Marketing
Notification Application with the US Food and Drug Administration for
the MERIDIAN™ Line of Non‐Invasive Fetal Heart Rate Monitors.
About the MERIDIAN M110 and M100 Non‐Invasive Fetal Heart Rate Monitor
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.
About the Fetal Heart Monitoring Market
Over 85%6 of the 4,000,0007 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 movement8.
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 infection9. There are an estimated
28,000 fetal monitors spread over 3,400 hospitals in the US10,
representing an investment of over $700,000,00011. MERIDIAN
has been developed to provide uninterruptible fECG data while addressing
the deficiencies in both Doppler and FSE via innovative non‐invasive
monitoring technology.
1 MindChild received 510(k) pre‐market clearance for the
MERIDIAN M1000 Fetal Heart Monitor September 19, 2012. MERIDIAN M1000 is
a stand‐alone Fetal heart Rate Monitor.
2 MERIDIAN Fetal Heart Monitor is protected by patents, both
issued and pending.
3 MERIDIAN 100 Fetal Heart Monitor received 510(k) pre‐market
clearance April 17, 2015.
4 Michael Ross, MD, MPH is a member of the MindChild Clinical
Advisory Board
5 MERIDIAN is supplied with single‐use proprietary electrodes
designed to monitor fetal heart rate.
6 “ACOG Refines Fetal Heart Rate Monitoring Guidelines”,
6/22/2009 The American College of Obstetricians and Gynecologists Press
Release
7 http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_03.pdf
8 Journal of Midwifery. Vol 18, No, 7: 424‐428. July 2010
9 American Family Physician, 1992 Feb;45(2):579‐82
10 http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html
11 Company estimates.
Contacts
MindChild Medical, Inc.
Bill Edelman, 781-436-0509
bill.edelman@mindchild.com
