AirStrip gets FDA clearance for its self-administered non-stress tests for prenatal care
SAN ANTONIO — The Food and Drug Administration on Wednesday cleared the AirStrip Sense4Baby wireless maternal/fetal monitoring system to be marketed for use in the United States by pregnant patients to self-administer non-stress tests.
Sense4Baby already received 510(k) clearance from the FDA for use accompanied by medical professionals. Sense4Baby also received the CE mark from the European Commission in 2013 for self-administration, including the home.
This new clearance is an important step toward integrating out-of-hospital perinatal monitoring data into the AirStrip ONE interoperable mobility platform and application. AirStrip ONE provides vendor- and data source-agnostic information from multiple data sources and care settings to support coordination among caregivers natively on smartphones, tablets and personal 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 Matt Patterson, AirStrip president. "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."
The University of Utah will conduct a research study to test AirStrip Sense4Baby in a local high-risk population. The goal is to assess the feasibility of integrating an at-home NST monitoring program into an established health care system, as well as to evaluate patient and provider satisfaction.
The University of Utah aims to show that mobile connectivity can positively impact prenatal care for both low- and high-risk pregnancies. Currently, NSTs are typically conducted in clinics or hospitals.
"Patients may need to travel for extended periods of time, multiple times per week, in order to receive these tests," said Erin Clark, assistant professor of maternal/fetal medicine in the Department of Obstetrics and Gynecology at Utah. "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 healthcare system. Strategies that employ mobile connectivity may be a key part of this vision."
The FDA clearance is the latest in a series of announcements since AirStrip acquired the assets of Sense4Baby in 2014. In February, AirStrip announced agreements to launch Sense4Baby in Europe, Africa and Australia/New Zealand. More international expansion announcements are expected soon.