The US Food and Drug Administration (FDA) has granted approval for the AirStrip Sense4Baby wireless maternal/fetal monitoring system, allowing the system to be used by pregnant patients to self-administer non-stress tests (NST).
Earlier, Sense4Baby obtained FDA 510(k) approval for use accompanied by medical professionals. It also received CE mark approval from the European Commission for self-administration, including the home, in 2013.
AirStrip president Dr 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."
The new approval helps in integrating out-of-hospital perinatal monitoring data into the AirStrip ONE interoperable mobility platform and application.
AirStrip ONE offers 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.
The University of Utah will carry out a research study to test AirStrip Sense4Baby in a local high-risk population, in a bid to assess the feasibility of integrating an at-home NST monitoring program into an established health care system and to evaluate patient and provider satisfaction.
Image: AirStrip Sense4Baby system has received FDA approval for patient self-administration. Photo: courtesy of PRNewswire/AirStrip.