FDA Approves OB-Tools’ Fetal Heart Rate Monitoring Unit
Israel-based OB-Tools said Wednesday that it has received FDA approval for a fetal heart rate monitoring unit to be used with its new TrueLabor maternal fetal monitor.
The company plans to begin marketing the system in the U.S. during the fourth quarter of this year, and in Europe during the first quarter of 2016.
The noninvasive TrueLabor monitor uses electrodes attached to the abdomen, measuring the minute electrical signals of uterine contractions and fetal heart beats. Mothers can move freely about the delivery room while this occurs.
OB-Tools CEO Gal Ben-David says the device’s unique algorithm both highlights the important uterine contraction information and filters out excess noise in the body that sometimes interferes with other monitors. — Michael Cipriano