FDA Clears AirStrip’s Sense4Baby for Home UseApril 14, 2015
The U.S. Food and Drug Administration (FDA) has granted market clearance for AirStrip’s Sense4Baby wireless fetal monitoring system to be used in self-administered non-stress tests (NST) by expectant mothers in the US. The device previously received 510(k) clearance from the FDA for use with the guidance of a medical professional.
The clearance will help enable remote perinatal monitoring data integration into the AirStrip ONE interoperable mobility platform and application from locations outside of the hospital. The AirStrip ONE provides information from multiple data sources and care settings to supplement coordination between caregivers via mobile devices and computers.
"AirStrip Sense4Baby can supplement care for patients with a prescribed need for NSTs that – with proper training and a care team's interpretation of data – offers a safe, convenient and cost-effective monitoring method in settings beyond hospital walls," said AirStrip President, Matt Patterson, M.D. "Sense4Baby is a natural extension of AirStrip ONE, creating a new avenue for seamless mobile monitoring that can connect patients with their care team while encouraging true patient engagement and peace of mind."
Following this announcement, the University of Utah will be conducting a research study to test the AirStrip Sense4Baby in a local high-risk population. It aims to assess the integration feasibility of the at-home NST monitoring program into an established health care system. Additionally, the study will also be evaluating patient and provider satisfaction with the device.
"Patients may need to travel for extended periods of time, multiple times per week, in order to receive these tests," said Erin A.S. Clark, MD, Assistant Professor of Maternal/Fetal Medicine in the Department of Obstetrics and Gynecology. "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 University of Utah strives to provide the very best prenatal care to our patients, with the highest patient satisfaction, at the lowest cost to patients and to the health care system. Strategies that employ mobile connectivity may be a key part of this vision."
With the advent of new fetal monitoring technology such as the AirStrip Sense4Baby in the market, healthcare providers and clinicians should ensure that their equipment is up-to-date and well-maintained. AIV provides an extensive selection of fetal monitoring transducers, accessories, replacement parts and repair services. To learn more about AIV’s fetal monitoring solutions, visit http://aiv-inc.com/fetal-monitor-transducers.html today.
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