OB-Tools announced that the US Food and Drug Administration (FDA) approval of its fetal heart rate monitoring unit. The fetal heart rate monitoring unit will be integrated into its new TrueLabor maternal fetal monitor.
TrueLabor is non-invasive, with electrodes easily attached to the outside of the body within seconds, allowing the mother to move about the delivery room freely, with no limitations. No special training, guesswork or tools is needed.
The monitor uses electrodes attached to the abdomen and measures the minute electrical signals of the uterine contractions and fetal heart beats. These signals are unaffected by body movement, coughing or obesity. The system is designed to work with any current monitoring system and electronic medical records.
"The real uniqueness of our device," according to its inventor, Ilan Calderon, MD, "is the algorithm invented by the OB-Tools Algorithm team. Our advance signal processing algorithm is what separates our device from the competition."
OB-Tools CEO Dr. Ben-David explains: "The algorithm not only highlights the important uterine contraction information but also filters out the excess noise in the body that sometimes interferes with other monitors." And he adds, "More importantly, our device can distinguish between true and false contraction and is not affected by movement, change of position, coughing, etc."
Clinical trials have found TrueLabor technology to be more reliable than the external fetal monitors and as accurate and reliable as the current invasive monitors on the market. OB-Tools’ new device is expected to provide more accurate detection of uterine activity and fetal status, thus reducing the need for invasive labor monitoring and the serious complications this can entail.
The TrueLabor system is anticipated to begin sales in the U.S. in Q4 2015 and in Europe during Q1 2016.
OB-Tools is dedicated to improving the well-being of pregnant women and fetal health through the continuous development of high quality and reliable uterine contraction and fetal heart rate monitoring devices that can be used throughout pregnancy and labor.