The U.S. FDA has cleared the AirStrip Sense4Baby wireless maternal/fetal monitoring system to be marketed for use in the country by pregnant patients to self-administer non-stress tests (NST).

Sense4Baby already has FDA’s 510(k) clearance for use accompanied by medical professionals, as well as EU’s CE mark for self-administration, including the home.

The University of Utah will conduct a research study to test AirStrip Sense4Baby in a local high-risk population.This new clearance, according to AirStrip, is an important step toward integrating out-of-hospital prenatal monitoring data into the AirStrip ONE platform and application. AirStrip ONE provides vendor- and data source-agnostic information from multiple data sources and care settings to support coordination among caregivers on smartphones, tablets and PCs.

“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.

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.

The FDA clearance is the latest in a series of announcements since AirStrip acquired the assets of Sense4Baby, Inc. in 2014. In February, AirStrip announced agreements to launch Sense4Baby in Europe, Africa and Australia/New Zealand.