FDA grants De Novo marketing authorization for at-home prenatal ultrasound
The U.S. Food and Drug Administration has just granted De Novo marketing authorization for an at-home prenatal ultrasound platform that allows patients to scan themselves.
Israel-based Pulsenmore Ltd. announced the authorization for its Pulsenmore ES on Monday. The product is an at-home prenatal ultrasound system physicians can prescribe to women so they can scan themselves under remote guidance via in-app instructions or a physician. Images captured are transmitted securely to the Pulsenmore app, where the provider can read them and inform the patient of any findings that might warrant an in-person visit.
Experts are hopeful the complementary tool can expand access to vital prenatal care, offering expectant mothers an added layer of reassurance.
"This is a long-awaited leap forward in obstetrical care," Wulf Utian, MD, PhD, who an expert in women's health, said of the news. "By reducing unnecessary visits, easing maternal anxiety and improving triage, Pulsenmore's innovation benefits patients, clinicians and healthcare systems alike."
The authorization comes as many experts and medical organizations have expressed concern over the maternal and fetal mortality rates in the U.S. in recent years. These rates in the U.S. are consistently higher than those reported in other developed countries—often double or triple the amount.
"Pulsenmore's solution bridges distance and capacity barriers, enabling physicians to stay connected to their patients throughout pregnancy," added Pulsenmore's CEO and founder Elazar Sonnenschein, MD. "Pulsenmore ES brings connected, clinician-led ultrasound directly into the home—making prenatal care more accessible and equitable."
The system is currently in use across Israel, Europe, Brazil and Australia. Pulsenmore said it has been used for over 200,000 patient scans so far. The company plans to partner with major U.S. healthcare systems to launch the product stateside in early 2026.
Learn more about the system here.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.