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:

Related Content

ECG Study of NBA Players Shows Need for Sport-Specific Normative Data and Guidelines
News | ECG | December 08, 2017
Cardiologists at NewYork-Presbyterian/Columbia University Irving Medical Center compared electrocardiographic findings...
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...
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 ...
Heart Test Laboratories, HTL, MyoVista ECG, common stock offering
News | ECG | January 31, 2017
Heart Test Laboratories Inc. (HTL) has successfully raised $12 million by way of a Common Stock private placement...
AirStrip One, ECG management, web client, U.S. clearance
Technology | ECG | October 11, 2016
The U.S. Food and Drug Administration (FDA) has issued 510(K) Class II clearance to a web client for the AirStrip One...
Carestream, Vue Motion universal viewer, ECG waveforms, diagnostic reading, FDA clearance

Image courtesy of Carestream Health

Technology | ECG | November 20, 2015
Carestream has obtained U.S. Food and Drug Administration (FDA) clearance for diagnostic reading of electrocardiogram (...
CardioSecur mobile ECG, 22-lead, 360 degree view of the heart, CardioSecur Pro

Image courtesy of CardioSecur

Technology | ECG | October 08, 2015
Personal MedSystems introduced the first and only 22-lead mobile electrocardiogram (ECG) system, CardioSecur, at the...
Mortara, ELI 280, TouchScreen ECG, ECG advances, new ECG technology

The Mortara Eli 280 is part of a new generation of ECG systems that integrate touchscreen monitors to improve workflow.

Feature | ECG | September 16, 2015 | Dave Fornell
The resting electrocardiogram (ECG) has been us
zebrafish, iWorx Systems Inc., ZS-200 Zebrafish ECG System, cardiac research
Technology | ECG | August 13, 2015
iWorx Systems Inc., developer of advanced physiology teaching and research instruments and software, has introduced a...
Overlay Init