Sep 26 2012
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™ non-invasive fetal heart monitor.
MindChild anticipates entering the US market with MERIDIAN now that it
has received the FDA clearance. Additional pre-market regulatory filings
are anticipated during 2012 and 2013.
"We are thrilled to have reached this milestone", stated Bill Edelman,
CEO. He continued, "MERIDIAN is the first in a series of non-invasive
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. We anticipate significant clinical
interest for this innovative technology in the markets where MERIDIAN
will be cleared for commercial distribution."
Adam Wolfberg, M.D., Chief Medical Officer for MindChild stated, "This
FDA pre-market 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."
Thomas Garite, M.D., Director of Research and Education for
the Obstetrix Medical Group, and Editor-In-Chief of the American Journal
of Obstetricians and Gynecology, commented, "I am excited to note the
FDA pre-market clearance of MERIDIAN. Accurate acquisition of the fetal
heart rate signal is critical to the safe practice of obstetrics.
Chronic increases in maternal obesity/Body-Mass-Index have created new
challenges for existing non-invasive fetal heart rate monitoring
technologies. This technology cannot help but to improve our ability to
make patient decisions. MindChild's Meridian non-invasive fetal
monitoring technology may hold the promise of such an advance."