MindChild Medical, Inc. Announces Clearance of a 510(k) Pre-Marketing Notification with the US Food and Drug Administration (FDA) for the MERIDIAN™ M110 Fetal Monitoring System
MERIDIAN Adds Uterine Contraction Monitoring to its Continuous
Non-Invasive Fetal Heart Rate Technology Using Surface Electrodes
NORTH ANDOVER, Mass.–(BUSINESS WIRE)–MindChild Medical, Inc. today announced that it has received clearance
for its Pre-Marketing Notification (510(k)) from the US Food and Drug
Administration (FDA) for its MERIDIAN™ M110 non-invasive fetal heart
monitor. MindChild anticipates entering the US market with MERIDIAN now
that it has received the FDA clearance.
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 (UA). The MERIDIAN
M110 Fetal Monitoring System acquires and displays 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 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 health care professionals
in a clinical setting.
“We are thrilled to have reached this milestone,” stated Bill Edelman,
CEO. He continued, “The MERIDIAN M110 Fetal Monitoring System is the
latest in a series of non-invasive fetal monitor technologies developed
by MindChild that are intended to provide the healthcare community
enhanced monitoring capabilities for both fetal heart rate, maternal
heart rate and uterine contraction, with a single set of disposable
abdominal surface electrodes. The MERIDIAN M110 has the potential to
provide essential fetal monitoring, replacing four separate monitoring
technologies now in use world-wide. We anticipate significant clinical
interest for this innovative technology in the markets where MERIDIAN
will be cleared for commercial distribution.”
Adam Wolfberg, M.D., Chief Medical Officer for MindChild stated, “This
FDA pre-market clearance delivers a highly-reliable fetal monitor to the
obstetric community. In the coming months and years, MindChild will
exploit this technology to improve the safety of obstetrics, and hand a
new diagnostic device to obstetricians and pediatric cardiologists.”
Previous Announcements
On December 7, 2015, MindChild
Medical, Inc. announced Receipt of Certificate of Registration by BSI
Group America Inc., Under the International Organization for
Standardization (ISO) 13485:2003.
On November 16, 2015, MindChild Medical, Inc. announced 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.
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 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 Non-Invasive Fetal Heart Rate Monitor
MERIDIAN
is a fetal monitor that non-invasively measures and displays fetal heart
rate (FHR). MERIDIAN acquires and displays the FHR tracing from
abdominal surface electrodes that detect the fetal ECG signal (fECG).
MERIDIAN is designed for women who are at term (≥ 37 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%1
of the 4,000,0002 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 movement3.
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 infection4. There are an estimated
28,000 fetal monitors spread over 3,400 hospitals in the US5,
representing an investment of over $700,000,0006. MERIDIAN
has been developed to provide uninterruptible fECG data while addressing
the deficiencies in both Doppler and FSE via innovative non-invasive
monitoring technology.
About MindChild Medical, Inc.
MindChild Medical, Inc., is a
privately funded medical device company founded in 2008. MindChild’s
principal technology platform, the MERIDIAN non-invasive fetal
electrocardiograph (fECG) monitor, is designed to report fetal heart
rate data equivalent to the gold standard fetal scalp electrode in
addition to novel ECG metrics intended to provide obstetricians a deeper
understanding of fetal/maternal health and management.
MindChild was co-founded by Adam Wolfberg, MD, Assistant Professor,
Tufts Medical Center, Gari Clifford, PhD, previously Principal Research
Scientist at Harvard-MIT Division of Health and Science Technology
(currently Interim Chair, Associate Professor, Biomedical Informatics
(Emory University)), James Robertson, President and CEO, and Jay Ward,
Executive Vice President, both of E-TROLZ, Inc. MindChild has
exclusively licensed intellectual property from the Massachusetts
Institute of Technology, Tufts Medical Center and E-TROLZ, Inc., a
Massachusetts technology company that develops and commercializes
breakthrough physiologic monitoring platforms for a wide variety of
applications.
For more information, please visit www.mindchild.com.
1 “ACOG Refines Fetal Heart Rate Monitoring Guidelines”,
6/22/2009 The American College of Obstetricians and Gynecologists Press
Release
2 http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_03.pdf
3
Journal of Midwifery. Vol 18, No, 7: 424-428. July 2010
4
American Family Physician, 1992 Feb;45(2):579-82
5 http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html
6
Company estimates.
Contacts
MindChild Medical, Inc.
Bill Edelman, 978-975-1160 x22
CEO
bill.edelman@mindchild.com
