Clinical Computer Systems, a leader in perinatal systems, has entered into a distributor agreement with a Swedish company, ObsteCare AB to launch a new product in North America, pending FDA 510K clearance that will help address some of the challenges around maternal health during labor and delivery.
Image: The ObsteCare product measures amniotic fluid lactate (AFL) levels to help labour management. Photo: Courtesy of Bokskapet from Pixabay.
The ObsteCare product measures amniotic fluid lactate (AFL) levels that offers clinicians the necessary information to help guide labor management during prolonged and/or dysfunctional labor.
Almost 40% of all women giving birth for the first time will experience prolonged labor. Prolonged labor puts pressure not only on the fetus and mother but also clinicians involved in their care. Measuring AFL during labor may help decrease caesarean sections, help individualize the use of oxytocin based on lactate levels and reduce postpartum complications.
“Currently, there’s an increased focus in U.S. to reduce caesarean sections and complications during childbirth. This product provides a new method with the potential to help address this common yet challenging problem. We are excited for the opportunity to bring this device to North America,” said CCSI CEO Kim Sell.
“We believe that we will receive the same positive response to our product in the US as we have from our customers in Europe. We are confident with this partnership and excited to work with CCSI. We look forward to obtaining the 510K clearance to begin the launch of AFL monitoring in North America,” said Johan Itzel, CEO of ObsteCare AB.
Assessing AFL during labor provides clinicians the needed information to make the best decision on how to proceed in the safest way for both mother and baby.
Source: Company Press Release.