FDA APPROVES NEW FETAL HEART MONITOR

The FDA has given Sweden-based Neoventa Medical approval to market the STAN S31 Fetal Heart Monitor. The device is a new type of fetal monitor that uses the fetal electrocardiogram obtained through a fetal scalp electrode during labor to help the doctor or midwife decide whether to allow the mother to continue to labor or to intervene and deliver the baby.

The monitor looks for changes in the fetal ECG that suggest the fetus is not adapting to the stress of labor. It is used when there is concern that the fetus might be at increased risk for metabolic acidosis.

For more information, visit http://www.fda.gov/cdrh/pdf2/p020001.html (http://www.fda.gov/cdrh/pdf2/p020001.html).

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