Mindchild Medical, Inc. news

(BusinessWire, North Andover, Massachusetts), 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 enteri

The Meridian Fetal Research Device Accurately Extracts Fetal ECG to Enable Analytics on Fetal ECG

Morphology, Heart Rate, Heart Rate Variability and Uterine Activity Using Surface Electrodes

(North Andover, Massachusetts), Mindchild Medical, Inc. announced that the LABOR study recorded its 6,000th subject with MindChild’s Meridian Fetal Research Device. Jay Ward, MindChild Medical’s Executive Vice President stated that “the data shows amazing performanc

The Meridian Fetal Research Device Accurately Extracts Fetal ECG to Enable Analytics on Fetal ECG Morphology, Heart Rate, Heart Rate Variability and Uterine Activity Using Surface Electrodes (North Andover, Massachusetts), MindChild Medical, Inc. today announced it has shipped 24 Meridian M110R Fetal Research Devices and 8,000 electrode patch sets to the UNC LABOR Study’s sites in developing countries of Zambia, Ghana, and India. All of the sites are fully trained on the use of Meridian

(North Andover, Massachusetts), MindChild Medical, Inc. today announced that the LABOR Study selected MindChild’s Meridian Fetal Research Device as the centerpiece of their study due to its unparalleled ability to accurately extract fetal ECG for advanced analytical research. Dr. Jeffrey Stringer, professor of obstetrics & gynecology in the UNC School of Medicine and LABOR Study Principal Investigator, stated that “of the nine companies evaluated, MindChild and their fetal res

MELVILLE, N.Y., April 25, 2019 – Henry Schein Medical, the U.S. Medical business of Henry Schein, Inc., and MindChild Medical, Inc. today announced the signing of an exclusive distribution and supply agreement for the MERIDIAN™ M110 Fetal Monitoring System. The MERIDIAN M110, currently available to Henry Schein customers, is an intrapartum fetal monitor that externally measures and displays fetal heart rate (FHR), maternal heart rate (MHR), and uterine contractions (UA). As part o

(BusinessWire, North Andover, Massachusetts), 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

(BusinessWire, North Andover, Massachusetts), MindChild Medical, Inc. today announced that it has received ISO 13485:2003 certification for the design, development and manufacturing of its MERIDIAN family of non-invasive Fetal Monitors1,2,3,4 . ISO 13485:2003 certification precedes European pre-market submission of a Technical File submission5 , enabling European commercialization of the MERIDAN family of Fetal Monitors. MindChild previously announced 510(k) pre-market clearance of the MERIDI

(BusinessWire, North Andover, Massachusetts), 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

(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 intend