AirStrip Receives FDA Clearance To Send Its Sense4Baby Monitor Home With Patients


Airstrip has received FDA clearance to move its Sense4baby fetal heart rate monitor out of the clinic and into patient homes. Currently, expecting mothers need to go to the hospital or their OB-GYN if a medical condition arises that requires the baby’s heart rate to be checked. This test, called a nonstress test, is one of the most common diagnostic procedures done during pregnancy, and is used to monitor fetal health in patients that develop gestational diabetes, preeclampsia, or even for reasons as simple as a mother who hasn’t felt her baby move or kick in too long.

With its extensive use in the maternity setting, there is a real opportunity to improve the patient experience, as well as drive down the cost of care, by introducing technology solutions that allow patients requiring frequent monitoring to self-administer the test from home. The monitor is worn around the patient’s belly and adjusted so that it can pick up a clear trace of the fetal heartbeat. Next, the device syncs with a paired smartphone or tablet app that runs the test and transmits the results back to the mother’s care team. The Sense4baby monitor was developed at the West Health Institute in California before being acquired by AirStrip in 2014.

With its clearance secured, Airstrip is moving forward with a pilot program at the University of Utah, where researchers will conduct at study using the Sense4baby wireless monitor in high-risk populations where at-home monitoring would be most impactful to the patient’s quality of life and the cost of care. Erin Clark, MD, Assistant Professor at the University of Utah explains, "Patients may need to travel for extended periods of time, multiple times per week, in order to receive these tests. At-home fetal monitoring may allow patients to save time and money related to travel for NSTs, and may also increase the capacity and flexibility of health systems to conduct NSTs.”

The news comes just as health systems pursuing value-based reimbursement models are looking for new ways of delivering care in lower cost settings. Airstrip had secured FDA clearance to market the device for use in clinics and hospitals in December 2013, but the device is much less compelling if its only benefit is its wireless features. Now, with the needed FDA clearance secured, Sense4baby can be sent home with patients requiring regular monitoring, which will free up hospital resources, and may reduce the overall cost of care associated with nonstress tests.

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