What's Happening?
Pulsenmore Ltd. has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its Pulsenmore ES, a home-use prenatal ultrasound platform. This device allows expectant
mothers to perform guided ultrasound scans at home, which are then interpreted by remote physicians. The Pulsenmore ES integrates with a smartphone app, providing step-by-step guidance and secure transmission of video clips to physicians for review. This innovation aims to address the limited access to obstetric services in the U.S., where 35% of counties are considered maternity care deserts. The platform has been clinically validated through trials at multiple academic and clinical institutions.
Why It's Important?
The FDA's authorization of Pulsenmore ES is significant as it introduces a new model of prenatal care in the U.S., potentially improving access to ultrasound services for expectant mothers, especially in underserved areas. By enabling home-based self-scanning with remote clinician review, the platform could reduce unnecessary clinic visits, ease maternal anxiety, and improve triage. This development aligns with the American College of Obstetrics and Gynecology's guidance for tailored prenatal care, offering a more accessible and equitable approach to prenatal monitoring.
What's Next?
Pulsenmore is preparing for a phased U.S. launch in early 2026, in collaboration with leading clinical institutions. The company aims to expand its home ultrasound platform, which is already in use in several countries, to support more than 200,000 patient scans with remote clinical interpretation. This expansion could further bridge distance and capacity barriers in prenatal care, enhancing the connection between physicians and patients throughout pregnancy.
