Pulsenmore Brings Home Ultrasound to U.S. with FDA Authorization

Pulsenmore Ltd. (TASE: PULS) has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for its Pulsenmore ES, a home-based prenatal ultrasound device designed to connect expectant mothers with their physicians through remote imaging review. The system enables pregnant individuals to perform guided scans at home using a smartphone-connected ultrasound cradle, with results interpreted by clinicians via a secure digital platform.

With this clearance, Pulsenmore brings to the United States a care model already used across healthcare systems in Israel, Europe, Brazil, and Australia. The technology has supported over 200,000 patient scans globally and is currently integrated into the workflows of major organizations such as Clalit Health Services and Sheba Medical Center. The company is now planning a phased U.S. launch in early 2026 in partnership with several clinical institutions.

The system was clinically validated in a multi-center trial conducted at four prominent academic and medical institutions in the U.S. During use, patients follow guided instructions through the Pulsenmore app while performing scans. Video clips are then securely uploaded to a physician dashboard for review, enabling physicians to maintain oversight of prenatal care without requiring patients to make additional in-person visits.

This approach is particularly timely in the U.S., where access to maternity care continues to face structural challenges. Recent data from the March of Dimes shows that over 35% of U.S. counties are classified as maternity care deserts. With 3.6 million babies born annually, the need for scalable solutions that reduce geographic and systemic barriers has never been more pressing.

The company emphasizes that the Pulsenmore ES is not intended to replace in-clinic diagnostic or anatomical ultrasound exams, but rather to complement routine care in line with recommendations from the American College of Obstetricians and Gynecologists (ACOG) for tailored prenatal delivery models. Dr. Alfred Abuhamad, Chair of Pulsenmore’s Medical Advisory Board, described the technology as a “transformative model for prenatal care—extending ultrasound access beyond the clinic and redefining how we reach and monitor expectant mothers.”

Pulsenmore’s leadership also highlighted the impact the technology could have on the overall care experience. “This is a long-awaited leap forward in obstetrical care,” said Dr. Wulf Utian, an internationally recognized 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.”

Dr. Elazar Sonnenschein, the company’s founder and CEO, framed the solution as one that bridges critical gaps. “Pulsenmore ES brings connected, clinician-led ultrasound directly into the home—making prenatal care more accessible and equitable,” he said.

CAUTION: Use of the Pulsenmore ES requires authorization from a prescribing physician.