Pulsenmore announced today that it received FDA de novo clearance for its home-use prenatal ultrasound platform.
The Pulsenmore ES platform enables expectant mothers to perform guided scans at home for interpretation by remote physicians. Authorization brings a proven care model connecting expectant mothers and physicians through guided imaging and secure digital review. The company says this comes amid growing constraints on access to obstetric services.
Pulsenmore said its platform integrates at-home ultrasound imaging into physician-led prenatal care. Its cradle connects to a patient’s smartphone and guides her step-by-step via a mobile app. Captured video clips securely transmit to physicians for review and interpretation on a dedicated dashboard.
The company says enabling home-based scanning with remote clinician review helps health systems expand access and improve the continuity of care while maintaining medical supervision in prenatal care.
Pulsenmore ES does not replace in-clinic diagnostic or anatomical ultrasound examinations. However, it complements existing workflows, the company says. It lands in alignment with the American College of Obstetrics and Gynecology Guidance for Tailored Prenatal Care Delivery for Pregnant Individuals.
The platform’s use already spans health systems across the world, supporting more than 200,000 patient scans. GE HealthCare delivered a $50 million investment in the company in 2022 and partnered to distribute its products in some markets.
Pulsenmore plans to begin a phased U.S. launch with leading clinical institutions in early 2026.
“Pulsenmore’s solution bridges distance and capacity barriers, enabling physicians to stay connected to their patients throughout pregnancy,” said Dr. Elazar Sonnenschein, Pulsenmore CEO and founder. “Pulsenmore ES brings connected, clinician-led ultrasound directly into the home-making prenatal care more accessible and equitable.”
