RAMAT GAN, Israel, Nov. 3, 2025 /PRNewswire/ -- 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.
According to the CDC, approximately 3.6 million babies are born in the U.S. each year, yet 35% of counties are considered maternity care deserts (March of Dimes, 2024). By enabling home-based self-scanning with remote clinician review, Pulsenmore ES helps health systems expand access and improve continuity of care while maintaining medical supervision at the center of prenatal care. "This is a long-awaited leap forward in obstetrical care," added Dr. Wulf Utian, an acknowledged world expert in women's health. "By reducing unnecessary visits, easing maternal anxiety, and improving triage, Pulsenmore's innovation benefits patients, clinicians, and healthcare systems alike."
The Pulsenmore ES does not replace in-clinic diagnostic or anatomical ultrasound examinations, but complements existing workflows in alignment with the American College of Obstetrics and Gynecology Guidance for Tailored Prenatal Care Delivery for Pregnant Individuals. "With FDA marketing authorization, Pulsenmore introduces a transformative model for prenatal care-extending ultrasound access beyond the clinic and redefining how we reach and monitor expectant mothers," said Dr. Alfred Abuhamad, Chairman of Pulsenmore's Medical Advisory Board.
Pulsenmore's home ultrasound platform is already in use across health systems in Israel, Europe, Brazil, and Australia, supporting more than 200,000 patient scans with remote clinical interpretation. The company partners with Clalit Health Services-one of the world's largest HMOs, and Sheba Medical Center, consistently ranked among the top 10 hospitals worldwide. Pulsenmore is preparing for a phased U.S. launch in collaboration with leading clinical institutions in early 2026.
"Pulsenmore's solution bridges distance and capacity barriers, enabling physicians to stay connected to their patients throughout pregnancy," said Dr. Elazar Sonnenschein, Pulsenmore's CEO and founder. "Pulsenmore ES brings connected, clinician-led ultrasound directly into the home-making prenatal care more accessible and equitable."
CAUTION: Access to the device operation must be granted by prescribing Physicians.
About Pulsenmore
Pulsenmore Ltd. (TASE: PULS) develops and commercializes home-use ultrasound solutions that securely connect patients and clinicians. Its mission is to make high-quality ultrasound accessible anytime, anywhere through self-scanning with clinical supervision.
Clinically validated and backed by large-scale commercial adoption, Pulsenmore's home ultrasound and telehealth platform supports hybrid prenatal care models across multiple global health systems.
For more information, visit www.pulsenmore.com
Media Contact:
Mira Altmark-Sofer
Vice President, Global Marketing, Pulsenmore Ltd.
Tel: +972-50-591-1212
Email: mira@pulsenmore.com
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