FDA Grants De Novo Clearance to Israeli Firm Pulsenmore for At-Home Pregnancy Ultrasound Device

In a significant regulatory milestone, the Israeli technology firm Pulsenmore secured De Novo clearance from the U.S. Food and Drug Administration (FDA) in November 2025. This authorization permits the marketing of the Pulsenmore ES device for at-home use during pregnancy. This marks the first time a consumer-grade, at-home ultrasound system has received such approval in the United States, effectively opening the door for the company to access a substantial market boasting approximately 3.6 million births annually.

The Pulsenmore ES unit is designed to interface directly with a user's smartphone. It facilitates scanning either through interactive guidance provided by an accompanying application or via real-time monitoring by a physician as part of a telemedicine service. This clearance represents a major regulatory achievement for consumer-facing medical diagnostics, particularly within the prenatal care sector. It validates the safety and efficacy of remote scanning when coupled with professional, off-site interpretation.

The timing of this approval is particularly salient given the severe shortage of obstetric care across the United States. According to a 2024 report published by March of Dimes, roughly 35% of U.S. counties are currently classified as maternal care deserts. These 1,104 counties lack any maternity ward or dedicated obstetrics staff, and they are home to over 2.3 million women of reproductive age. The Pulsenmore ES offers a potential pathway to bridge some of this critical access gap.

Pulsenmore emphasizes that the ES device is intended to supplement, rather than replace, established prenatal care routines, including in-person diagnostic or triage ultrasound examinations, aligning with the guidelines set forth by the American College of Obstetricians and Gynecologists (ACOG). The device’s clinical safety and effectiveness were rigorously demonstrated through a multicenter trial involving four prominent American academic and clinical institutions: Mount Sinai, Brigham and Women's Hospital, the University of Florida, and the Los Angeles Center for Women's Health.

Dr. Elazar Sonnen Schein, the CEO and founder of Pulsenmore, commented that this approval validates the company’s core vision of making medicine more accessible. He stated that the clearance successfully brings “clinician-guided connected ultrasound right into the home.” This integration of remote guidance and personal device technology is poised to redefine certain aspects of prenatal monitoring.

Beyond the U.S. market, Pulsenmore technology is already commercially active, having supported over 200,000 patient scans across various regions, including Israel, Europe, Brazil, and Australia. The company intends to roll out its product in the U.S. in a phased launch beginning in early 2026. Once launched, the device will qualify for reimbursement under existing U.S. billing codes for Limited Ultrasound services.

The technological backbone of the Pulsenmore system features a proprietary ASIC chip, developed in collaboration with Japan’s Seiko. This innovation allows for image processing to be offloaded directly to the smartphone, which helps keep the cost of the physical scanning unit down. Dr. Alfred Abuhamad, who chairs Pulsenmore’s Medical Advisory Board, underscored the importance of the clearance, noting that it introduces a proven care model to the U.S. that effectively connects expectant mothers and their physicians through managed visualization.