Pulsenmore said the FDA has granted De Novo marketing authorization for the Pulsenmore ES, a home-use prenatal ultrasound platform that enables expectant mothers to perform guided scans at home and have them interpreted by remote physicians.
This authorization introduces to the U.S. a care model that connects expectant mothers and physicians through guided imaging and secure digital review.
The Pulsenmore cradle connects to the patient's smartphone and guides them step-by-step via the Pulsenmore app. Captured video clips are securely transmitted to physicians for review and interpretation on a dedicated dashboard. Pulsenmore's U.S. clinical validation was achieved through a multi-center trial conducted at four leading academic and clinical institutions.
The Pulsenmore ES does not replace in-clinic diagnostic or anatomical ultrasound examinations, but complements existing workflows in alignment with the American College of Obstetrics and Gynecology Guidance for Tailored Prenatal Care Delivery for Pregnant Individuals.
Pulsenmore's home ultrasound platform is already in use across health systems in Israel, Europe, Brazil, and Australia. The company partners with Clalit Health Services, one of the world's largest HMOs, and Sheba Medical Center. Pulsenmore is preparing for a phased U.S. launch in collaboration with clinical institutions in early 2026.
