MindChild Medical, Inc. Announces Publication of “Evaluation of the fetal QT interval using non-invasive fetal ECG technology” With the MERIDIAN™ Fetal Monitoring System
The MERIDIAN Fetal Monitoring System Enables Non-Invasive Fetal,
Maternal Heart Rate and Uterine Contraction Monitoring Using Surface
Electrodes
NORTH ANDOVER, Mass.–(BUSINESS WIRE)–MindChild Medical, Inc. today announced publication of “Evaluation of
the fetal QT interval using non-invasive fetal ECG technology” in the
Journal of Physiological Measurement.1 The evaluation was
conducted by investigators at Technion-IIT, University of Oxford, Tufts
Medical Center, Boston Children’s Hospital, Seattle Children’s Hospital,
Brigham and Women’s Hospital, MindChild Medical, Emory University and
Georgia Institute of Technology. Utilizing MERIDIAN non-invasive fetal
electrocardiography (NI-FECG) technology enables accurate extraction of
the fetal QT interval. According to senior author, Gari D. Clifford, PhD2,3,
“These results provide evidence that non-invasive fetal
electrocardiography (NI-FECG) technology enables accurate extraction of
the fetal QT interval.” Dr. Clifford continued, “Fetal QT interval
changes are critical in managing fetal health. The ability to extract
high quality fetal QT intervals may have profound diagnostic
implications and provide insight to proactive fetal management.” Long QT
syndrome (LQTS) has been shown to be a major determinant in young sudden
death individuals for which an autopsy was performed but had remained
inconclusive4 and a determinant for as much as 10% of sudden
infant death syndrome (SIDS).5,6,7
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 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 healthcare professionals
in a clinical setting.
Adam Wolfberg, M.D., Chief Medical Officer for MindChild stated, “The
ability of extract accurate fetal electrocardiographic information is a
tremendous achievement. As this technology enters the labor and delivery
clinic, new diagnostic capabilities will undoubtedly emerge, providing
insight into fetal management not currently available.” Dr. Wolfberg
continued, “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 January 17, 2017, MindChild Medical, Inc. announced clearance 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 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. 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%8 of the 4,000,0009 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 movement10.
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 infection11. There are an estimated
28,000 fetal monitors spread over 3,400 hospitals in the US12,
representing an investment of over $700,000,00013. 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 Physiol. Meas. 37 (2016) 1392–1403.
2 Gari Clifford, PhD is the Chief Technology Officer of
MindChild, Inc.
3 Presently Interim Chair, Associate Professor, Biomedical
Informatics (Emory University) and Associate Professor, Biomedical
Engineering (Georgia Institute of Technology)
4 Mayo Clin Proc. 2012 Jun; 87(6):524-39.
5 JAMA. 2001 Nov 14; 286(18):2264-9.
6 Circulation. 2007;115(3):361–367.
7 Heart Rhythm. 2009;6(2):272–278.
8 “ACOG Refines Fetal Heart Rate Monitoring Guidelines”,
6/22/2009 The American College of Obstetricians and Gynecologists Press
Release
9 http://www.cdc.gov/nchs/data/nvsr/nvsr59/nvsr59_03.pdf
10 Journal of Midwifery. Vol 18, No, 7: 424-428. July 2010
11 American Family Physician, 1992 Feb;45(2):579-82
12 http://www.aha.org/aha/resource-center/Statistics-and-Studies/fast-facts.html
13 Company estimates.
Contacts
MindChild Medical, Inc.
Bill Edelman, 978-975-1160 x22
CEO
bill.edelman@mindchild.com
