Tags: FDA, fetal heart monitor, fetal monitor, fetal monitoring system, medical device, medical devices, medical technology, MERIDIAN M110, mindchild, U.S. Food and Drug Administration
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MindChild Medical, Inc., a client of MBBP, has received FDA clearance for its Pre-Marketing Notification (510(k)) for its MERIDIAN™ M110 non-invasive fetal heart monitor. The FDA clearance will enable MindChild to enter the U.S. market with MERIDIAN™.
MindChild’s MERIDIAN™ M110 Fetal Monitoring System is an intrapartum fetal monitor that externally measures and displays fetal heart rate, maternal heart rate, and uterine contractions.
Congratulations to MindChild on this achievement!
FDA Clears MindChild Medical’s Fetal Monitor 10/23/2012Posted by Morse Barnes-Brown Pendleton in Client News.
Tags: FDA, fetal monitor, meridian, mindchild
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In February we reported that MBBP client MindChild Medical Inc. had filed for a Pre-Marketing Notification Application (510(k)) with the U.S. Food and Drug Administration for its non-invasive fetal heart rate monitor, MERIDIAN™. On September 25, MindChild announced that the FDA has cleared MERIDIAN™ and anticipates it entering the U.S. markets in the near future. Bill Edelman, CEO of MindChild, had this to say of the achievement:
We are thrilled to have reached this milestone. 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.
Please view the press release for more information.