Technology | September 28, 2012

FDA Clears MindChild’s Meridian Noninvasive Fetal Heart Rate Monitor

Meridian provides continuous noninvasive fetal heart rate readings using surface electrodes

MindChild Medical Inc. Meridian Fetal ECG

September 28, 2012 — MindChild Medical Inc. announced that it has received 510(k) premarketing notification clearance from the U.S. Food and Drug Administration (FDA) for its Meridian noninvasive fetal heart monitor, and anticipates entering the U.S. market with Meridian soon. Additional pre-market regulatory filings are anticipated during 2012 and 2013.

“We are thrilled to have reached this milestone,” said Bill Edelman, CEO. “Meridian is the first in a series of noninvasive fetal monitor technologies developed by MindChild that are intended to provide the healthcare community enhanced monitoring capabilities for both fetal heart rate and fetal ECG (fECG). We anticipate significant clinical interest for this innovative technology in the markets where Meridian will be cleared for commercial distribution.”

“This FDA premarket 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,” said Adam Wolfberg, M.D., chief medical officer for MindChild.

Thomas Garite, M.D., director of research and education for the Obstetrix Medical Group, said, “I am excited to note the FDA premarket clearance of Meridian. Accurate acquisition of the fetal heart rate signal is critical to the safe practice of obstetrics. Chronic increases in maternal obesity/BMI (body mass index) have created new challenges for existing noninvasive fetal heart rate monitoring technologies. This technology cannot help but to improve our ability to make patient decisions. MindChild's Meridian noninvasive fetal monitoring technology may hold the promise of such an advance.”

For more information: www.mindchild.com

Related Content

Fysicon Receives FDA Approval for QMAPP Hemodynamic Monitoring System
Technology | Hemodynamic Monitoring Systems| September 18, 2017
Fysicon announced that it has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its...
HeartSciences Announces CE Mark and European Launch of MyoVista High Sensitivity ECG

Just as a Doppler radar color image shows the energy of a storm, MyoVista provides physicians a detailed visual image of the energy distribution during the cardiac cycle.

News | ECG| August 22, 2017
HeartSciences announced the European launch of the MyoVista high sensitivity electrocardiograph (hsECG) Testing Device...
AUM Cardiovascular Receives FDA Approval for CADence ECG Device
Technology | ECG| August 08, 2017
AUM Cardiovascular announced it has received clearance from the U.S. Food and Drug Administration (FDA) for CADence, a...
Wearable monitors create patient generated health data, PGHD, that can help prevent acute care episodes in heart failure.

Wearable monitoring devices may offer a new tool to help prevent acute care episodes in heart failure.

Feature | Heart Failure| July 25, 2017 | Lola Koktysh
Despite their best efforts, many patients tend to develop heart failure after an acute event (e.g., a heart attack or
More Than 20 Percent of Low-Risk Patients Receive Annual ECG
News | ECG| July 20, 2017
July 20, 2017 — More than one in five Ontario patients receive an ...
Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients
News | Heart Failure| July 14, 2017
A review appearing in the July 18 issue of the Journal of the American College of Cardiology (JACC) discusses current...
Cardiologs ECG Analysis Platform Receives FDA Clearance
Technology | ECG Monitoring Services| July 13, 2017
Cardiologs Technologies SAS announced that it has received U.S. Food and Drug Administration (FDA) clearance of its...
monitoring a heart failure patient's chest fluid buildup with remote monitoring using the SensiVest

A heart failure patient wearing the SensiVest remote monitoring system for a two-minute a day assessment. 

News | Heart Failure| July 13, 2017
July 13, 2017 — About 5.7 million adults in the U.S.
Videos | Heart Failure| July 13, 2017
William Abraham, M.D., director of the Division of Cardiovascular Medicine at The Ohio State University Wexner Medica
iRhythm and Stanford Researchers Develop Deep Learning-Based Cardiac Arrhthymia Detection Algorithm
News | Artificial Intelligence| July 11, 2017
iRhythm Technologies Inc. announced a collaboration with the Stanford Machine Learning Group that has resulted in the...
Overlay Init