Signals from disposable sensors track cervix dilation and fetal head descent, providing continuous and accurate data throughout the birthing process.In 2001, Israeli obstetrician Dr. Dan Farine came to the conclusion that there had to be a better way to measure …
With encouragement from colleagues who felt the same, Farine, who teaches at the University of Toronto, turned to two of his Israeli friends for help – Ofer Barnea, a professor of biomedical engineering at the University of Tel Aviv and Shlomo Nevo, an industrialist.
Together, the men set up the company Barnev at the Naiot Venture Accelerator to develop a device that would perform the cervix examination electronically.
Six years on, Barnev’s Computerized Labor Monitoring System (CLM) has just received approval from the Food and Drug Administration (FDA) for use in the US – which is likely to be great news for the estimated four million American women who give birth each year.
Developed at Barnev’s Netanya-based R&D facility, the CLM makes labor safer and easier for women, according to the company’s CEO Yossi Machtey, while providing doctors with better data, which in turn enables them to offer better care to patients.
Traditionally, monitoring the progress of labor must be done through intrusive and repeated manual examinations. Measurements are generally obtained every one to four hours by inserting the fingers towards the cervix. Measured by finger-lengths and not objective measurements, multiple examinations even by the same person often provide varied results. These uncomfortable examinations increase stress and anxiety for birthing mothers while increasing health risks.
The CLM uses proprietary ultrasound technology to monitor the progression of labor. Signals from disposable sensors track cervix dilation and fetal head descent, providing continuous and accurate data throughout the birthing process. The results are available in real-time on a user-friendly monitor visible to both the medical team and the birthing mother.
The device provides early warning of problems in delivery, which enables doctors to respond rapidly, reducing the need for later medical intervention. For the birthing mother, access to information throughout labor helps reduce stress.
“We’ve seen in our clinical trials that the labor room is much more tranquil because women see exactly what is happening,” Machtey told ISRAEL21c.
While the woman giving birth is the primary recipient of the advantages offered by CLM, medical professionals are also enjoying the benefits of accurate data over subjective guesses in monitoring the progress of labor.
“A multi-center clinical trial, conducted internationally including in the United States, has shown the CLM to be an effective and accurate tool in monitoring the progress of labor,” said Farine, who today heads Barnev’s medical advisory board. “We are confident that the CLM will help obstetricians and midwives make truly informed decisions during labor, expedite their decision making process and potentially reduce the various risks of delivery.”
In addition, use of the CLM can potentially lower the cost of malpractice, a common concern in the medical profession. Machtey noted that, “the data collected by the CLM can be introduced in litigation, should such a situation arise.”
According to Machtey, the CLM is currently the only alternative to manual examinations on offer to hospitals.
“This is the only technology that has been approved by the FDA,” he said, adding that in addition, Barnev obtained European Union CE Mark certification in 2006.
Recently exhibited at the 27th Annual Meeting of the Society for Maternal-Fetal Medicine (SMFM) in San Francisco to a warm reception, the CLM is still in its early stages of distribution. Barnev, which raised $6 million in investment from Israeli investors in 2006, is initially interested in introducing this product to universities and medical centers in the US in order to generate further interest.
“Women who participated in the clinical trial with the birth of their first child, called and asked for the product to be used with subsequent births. They liked the CLM because they knew what was happening,” Machtey said.
Asked if his wife would have appreciated a computerized labor-monitoring device when giving birth, Machtey laughed and said “she would have loved it!”