FDA Grants De Novo Approval for Home Use of Prenatal Ultrasound Platform

The Pulsenmore ES home-use prenatal ultrasound platform has garnered De Novo approval from the Food and Drug Administration (FDA).

Pulsenmore, the developer of Pulsenmore ES, emphasized that home use of the Pulsenmore ES ultrasound system can be integrated into current prenatal care workflows. By connecting the cradle of the Pulsenmore ultrasound system to a smartphone, Pulsenmore said expectant mothers can utilize an app for step-by-step ultrasound guidance and secure transmission of ultrasound video clips for remote interpretation.

Noting that the Pulsenmore ES system has already being utilized for 200,000 patient scans in Israel, Europe, Australia and Brazil, the company suggested home use of the modality may have an impact in facilitating care for women in maternity care deserts, which reportedly comprise 35 percent of counties in the United States.

"This is a long-awaited leap forward in obstetrical care," added Wulf Utian, M.D., a consultant in women’s health at the Cleveland Clinic Foundation and the medical director emeritus at the North American Menopause Society. "By reducing unnecessary visits, easing maternal anxiety, and improving triage, Pulsenmore's innovation benefits patients, clinicians, and health-care systems alike."

Pulsenmore is targeting a phased launch of the Pulsenmore ES ultrasound platform for early 2026.