Pulsenmore's FDA Clearance Marks Shift in Prenatal Care

Pulsenmore Ltd., based in Ramat Gan, Israel, has obtained the FDA's De Novo marketing authorization for its home-use prenatal ultrasound platform, Pulsenmore ES. This innovation allows expectant mothers in the U.S. to perform guided ultrasound scans at home, with images reviewed by remote physicians.

In response to limited obstetric service access, this model enhances prenatal care by integrating at-home imaging with physician supervision. The Pulsenmore ES connects to a smartphone through an app, securely transmitting scan results to a dedicated physician dashboard. Clinical trials were conducted at several major U.S. institutions to validate this approach.

The Pulsenmore ES aims to improve access without replacing traditional in-clinic procedures. It is already used in Israel, Europe, Brazil, and Australia, with plans for a U.S. rollout in 2026.