US-based AirStrip Technologies has received a second 510(k) clearance from the US Food and Drug Administration (FDA) for Sense4Baby wireless maternal l/ fetal monitoring system for use by pregnant patients to self-administer non-stress tests (NST).
Sense4Baby is a maternal and fetal monitoring product developed by West Health and later acquired by AirStrip.
The FDA had already granted 510(k) clearance for Sense4Baby for use accompanied by medical professionals.
AirStrip president Matt Patterson said: "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.
"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 new FDA clearance will see a new study conducted at the University of Utah, which will test Sense4Baby in high-risk population.
The study is designed to evaluate the feasibility of integrating an at-home NST monitoring programme into an established health care system, as well as to evaluate patient and provider satisfaction.
One of the main aims of the University of Utah is to show that mobile connectivity can positively impact prenatal care for both low- and high-risk pregnancies.
The new clearance also helps in 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.
In 2013, the system also secured the CE mark from the European Commission (EC) for self-administration, including the home.
Image: AirStrip Sense4Baby system has received FDA approval for patient self-administration. Photo: courtesy of PRNewswire/AirStrip.