Pulsenmore: Home Ultrasound De Novo Authorization

Pulsenmore Ltd. (TASE: PULS), a pioneer in home ultrasound solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for the Pulsenmore ES, a home-use prenatal ultrasound platform that enables expectant mothers to perform guided scans at home interpreted by remote physicians.  This authorization introduces to the United States a proven care model that connects expectant mothers and physicians through guided imaging and secure digital review- amid growing constraints on access to obstetric services.

The Pulsenmore ES integrates at-home ultrasound imaging into physician-led prenatal care. The Pulsenmore cradle connects to the patient's smartphone and guides her step-by-step via the Pulsenmore app. Captured video clips are securely transmitted to physicians for review and interpretation on a dedicated dashboard. Pulsenmore's U.S. clinical validation was achieved through a multi-center trial conducted at four leading academic and clinical institutions.