Massachusetts-based medical device company MindChild looks to commercialize a sophisticated fetal heart monitor and reduce the number Caesarean sections for pregnant women.
MindChild Medical received 510(k) clearance from the U.S. FDA for a new fetal heart monitor the company says can detect tiny fluctuations in fetal heartbeats and potentially reduce the number of Caesarean sections pregnant women undergo.
Company officials said the regulatory win clears the way for the company to commercialize its Meridian non-invasive fetal heart monitor.
"We are thrilled to have reached this milestone," CEO Bill Edelman said in prepared remarks. "Meridian is the 1st 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."