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