Pulsenmore has received FDA De Novo marketing authorization for its home-use prenatal ultrasound platform. The authorization allows pregnant individuals to perform guided ultrasound scans at home for remote physician interpretation.
The Pulsenmore ES connects to a smartphone and guides users through scans via an app. Video clips are transmitted securely to physicians who review and interpret them through a dedicated dashboard. The device received authorization following a multi-center clinical trial at four U.S. academic and clinical institutions.
The platform addresses a significant access gap in prenatal care. According to the CDC, approximately 3.6 million babies are born across the United States annually, yet 35% of counties lack adequate maternity care access, according to March of Dimes 2024 data.
“This is a long-awaited leap forward in obstetrical care,” said Dr. Wulf Utian, a women’s health expert. “By reducing unnecessary visits, easing maternal anxiety, and improving triage, Pulsenmore’s innovation benefits patients, clinicians, and healthcare systems alike.”
The device does not replace in-clinic diagnostic or anatomical ultrasound examinations. Instead, it complements existing prenatal care workflows in alignment with American College of Obstetrics and Gynecology guidance for tailored prenatal care delivery.
“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 used 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 and Sheba Medical Center in Israel.
The company plans a phased U.S. launch in collaboration with clinical institutions in early 2026. Access to the device requires a prescription from a physician.
“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.”
