Sense4Baby, the maternal and fetal monitoring product developed by West Health and then acquired by AirStrip Technologies, has received a second FDA 510(k) clearance, which will allow pregnant mothers to perform non-stress tests in their homes. The technology was previously only cleared for use by providers in clinical settings.
The Sense4Baby offering is a packaged kit that includes the wearable monitoring device and either a dedicated smartphone or tablet with pre-loaded Sense4Baby software. The company also offers providers a web-based portal that allows doctors to view or review all data entered through the mobile app as well as the monitoring data. It received its first FDA clearance in December 2013.
When AirStrip Technologies bought Sense4Baby to build its functionality into its AirStrip One interoperable mobility platform and application, the company announced that it planned to bring it to the home.
"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," AirStrip President Dr. Matt Patterson said in statement. "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 opens the door for a new study at the University of Utah, which will test Sense4Baby in high-risk population. It will be a feasibility study for at-home testing, and will also measure doctor and patient satisfaction with the platform.
"Patients may need to travel for extended periods of time, multiple times per week, in order to receive these tests," Dr. Erin A.S. Clark, an assistant professor of maternal and fetal medicine in the Department of Obstetrics and Gynecology at the University of Utah, said in a statement. "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."