The maker of an Israeli DIY ultrasound device that allows pregnant women to see their baby in the womb at any time has launched a new clinical study to assess its ability to conduct a test to measure the health of the fetus.
The test to conduct a remote biophysical profile (BPP) test using Pulsenmore is being carried out in association with Michigan Medicine, the University of Michigan’s academic medical center.
The BBP test is normally carried out in a clinical setting and assesses criteria such as the movement and breathing of the fetus using an ultrasound. The new study aims to see whether it can be carried out in the home using Pulsenmore, with with remote guidance from a clinician.
Women in Israel are already able to obtain the Pulsenmore device through their healthcare providers and the company is aiming to expand internationally, holding approvals for marketing in Australia, Brazil. Europe, Switzerland and the UK.
“Prenatal care delivery has undergone drastic changes since the COVID-19 pandemic, including a rapid growth in virtual prenatal visits,” said Dr. Alex Peahl, an assistant professor in the department of obstetrics and gynecology at the University of Michigan and the principal investigator of the study.
“The BPP 4 Me study puts pregnancy monitoring tools in patients’ hands, allowing patients to complete Biophysical Profiles (BPPs), tests of fetal wellbeing, from anywhere. BPP 4 Me is the first step towards a new patient-centered model of prenatal care that can reduce care burden and barriers while empowering patients, particularly those most marginalized by our current health care system,” she said.
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