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NICHD Experts Validate EFM Analysis by PeriCALM Patterns
Software Can Be Used To Screen In Real Time When An Expert Is Not Present
Princeton, NJ, January 15, 2013 – PeriGen, Inc., the global leader in applying real-time clinical decision support to perinatal systems, today announced the results of an independent validation study on fetal strip interpretation favorably comparing PeriGen PeriCALM® Patterns software with the findings of three experts from the National Institute of Health (NIH). The FDA-cleared fetal strip interpretation technology is a component of the company’s perinatal central surveillance offering.
The study reviewed the analysis of PeriCALM Patterns during the final hour of 100 tracings, and concluded that, “computerized fetal heart rate interpretation has substantial agreement with experts’ evaluation. The software can be used to efficiently evaluate stored fetal heart rate data retrospectively as well as to screen in real time when an expert is not continuously evaluating the fetal heart rate,” as reported by Steven Wiener of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Maternal-Fetal Medicine Units Network, Bethesda, Maryland. In over 97 percent of the assessments, the experts agreed with the analysis by PeriCALM Patterns.
This validation study is the first phase of a research collaboration announced earlier in 2012, Computerized Interpretation of Intrapartum FHR and Prediction of Neonatal Outcomes, with primary investigators George R. Saade, MD, University of Texas Medical Branch in Galveston, Texas, and Sean Blackwell, MD, University of Texas at Houston-Children’s Memorial Hermann Hospital. The findings will be presented at the Annual Clinical Meeting of the Society of Maternal Fetal Medicine (SMFM) in San Francisco on February 16, 2013 and were published in the American Journal of Obstetrics and Gynecology, Vol. 208, Issue 1, Supplement S316-S317.
“We are delighted by the results,” commented Dr. Emily Hamilton, Senior Vice President of Clinical Research, PeriGen. “Internationally recognized experts participated in this extensive and completely independent test. These results demonstrate that clinicians can have confidence in the use of PeriCALM at the bedside. In addition, other researchers can rely upon the software to consistently analyze thousands of tracings retrospectively and test new scientific hypotheses to clarify what combination of FHR features are truly indicative of impending birth related hypoxic injury. ”
“PeriCALM Patterns from PeriGen provides far more clinical insight than other central perinatal surveillance systems into what is arguably the most subjective and highest risk task in delivering a baby – interpreting the fetal monitoring strip,” said PeriGen CEO Matthew Sappern. “The incremental insight provided by PeriCALM Patterns means better information for making clinical decisions and promoting improved outcomes.”
About the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The NICHD sponsors research on development before and after birth; maternal, child and family health; reproductive biology and population issues; and medical rehabilitation. For more information, visit the Institute’s website at http://www.nichd.nih.gov/.
About the Society of Maternal Fetal Medicine (SMFM).
The SMFM is a Society of physicians and scientists who are dedicated to the optimization of pregnancy and perinatal outcomes. Their mission is twofold: improving maternal and child outcomes and raising the standards of prevention, diagnosis and treatment of maternal and fetal disease through support for the clinical practice of maternal-fetal medicine, research, education/training, advocacy and health policy leadership. For more information, visit www.smfm.org
About PeriGen, Inc.
PeriGen. Inc., is an innovative provider of fetal surveillance systems employing patented, pattern-recognition and obstetrics technologies that empower perinatal clinicians to make confident, real-time decisions about the mothers and babies in their care. PeriGen’s customer-centric team of clinicians and technologists builds the most advanced systems available to augment obstetric decision-making and improve communications among the clinical team at the point of care, while supporting data flow between healthcare IT systems.
PeriGen’s unique fetal surveillance products provide dynamic visual cues that direct clinicians to the most essential patient information displayed on the screen. Unlike legacy fetal monitoring devices and software from non-specialist companies, PeriGen Visual Cueing™ provides an instant view of the mother’s and baby’s current status and trends over time to avoid errors, increasing patient safety and reducing risk for clinicians and hospitals. For more information, please visit us at www.PeriGen.com.