Jerusalem, 3 November, 2025 (TPS-IL) — Israeli medtech company Pulsenmore Ltd. has received FDA De Novo marketing authorization for its home-use prenatal ultrasound platform, Pulsenmore ES. The device allows expectant mothers to perform guided scans at home, with images securely transmitted to physicians for remote review.
Already widely used in Israel, Europe, Brazil, and Australia, Pulsenmore ES aims to improve prenatal care access in the U.S., particularly in maternity care deserts affecting 35% of counties. The company plans a phased U.S. launch with leading clinical institutions in early 2026, bridging distance and capacity gaps in prenatal health.