Pulsenmore Earns FDA De Novo Nod for Home Prenatal Ultrasound

Pulsenmore, a pioneer in home ultrasound solutions, has earned U.S. Food and Drug Administration (FDA) de novo clearance for Pulsenmore ES, a home-use prenatal ultrasound platform that lets expectant mothers perform guided scans at home interpreted by remote physicians.

The authorization introduces to the U.S. a care model that connects expectant mothers and physicians through guided imaging and secure digital review amid rising constraints on access to obstetric services, the company said.

Pulsenmore ES merges home ultrasound imaging with physician-led prenatal care. The Pulsenmore cradle connects to the patient’s smartphone and guides her step-by-step with the Pulsenmore app. Captured video is securely transmitted to physicians for review and interpretation on a dashboard.

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,” said 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.”

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The company advised the device doesn’t replace in-clinic diagnostic or anatomical ultrasound exams, but complements existing workflows in alignment with American College of Obstetrics and Gynecology Guidance for Tailored Prenatal Care Delivery for Pregnant Individuals.

The home ultrasound platform is used in health systems in Israel, Europe, Brazil, and Australia, supporting over 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).

The company is preparing for a phased U.S. launch in 2026, in collaboration with leading clinical institutions.

“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.”