Pulsenmore Secures FDA De Novo Clearance for Home-Use Prenatal Ultrasound Platform
Pulsenmore has received De Novo marketing authorization from the U.S. Food and Drug Administration (FDA) for the Pulsenmore ES, a home-use prenatal ultrasound system that allows expectant mothers to perform guided scans at home, with images reviewed and interpreted remotely by physicians. The approval marks a milestone in prenatal care innovation and introduces a new tele-ultrasound model to the U.S. market.
The Pulsenmore ES connects to a user’s smartphone via a cradle and operates through the Pulsenmore app, which provides real-time guidance during the scanning process. The recorded ultrasound clips are securely transmitted to clinicians through a dedicated platform for evaluation and feedback. The system underwent multi-center clinical validation across four major academic and medical institutions in the U.S., demonstrating its reliability and usability for home-based care.
According to the March of Dimes, 35% of U.S. counties qualify as maternity care deserts, limiting access to regular prenatal monitoring for millions of women. By combining self-scanning with remote physician oversight, Pulsenmore aims to extend access while maintaining medical supervision as the core of prenatal care. “This is a long-awaited leap forward in obstetrical care,” said Dr. Wulf Utian, a noted women’s health expert. “By reducing unnecessary visits, easing maternal anxiety, and improving triage, Pulsenmore’s innovation benefits patients, clinicians, and healthcare systems alike.”
While the Pulsenmore ES does not replace in-clinic diagnostic ultrasounds, it complements traditional workflows in line with the American College of Obstetricians and Gynecologists’ recommendations for personalized prenatal care. “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 platform is already deployed in Israel, Europe, Brazil, and Australia, with over 200,000 patient scans completed under remote clinical supervision. The company collaborates with Clalit Health Services and Sheba Medical Center, both leaders in digital healthcare. A phased U.S. rollout is planned for early 2026, supported by partnerships with major clinical institutions.
“Pulsenmore’s solution bridges distance and capacity barriers, enabling physicians to stay connected to their patients throughout pregnancy,” said Dr. Elazar Sonnenschein, CEO and founder of Pulsenmore. “Pulsenmore ES brings connected, clinician-led ultrasound directly into the home—making prenatal care more accessible and equitable.”
CAUTION: Device use requires physician authorization.
