Shares of Pulsenmore, the Israeli pioneer of at-home ultrasound for pregnant women, jumped 33% Sunday on the Tel Aviv Stock Exchange after the company announced it had received FDA clearance to sell its device in the United States.
The Pulsenmore ES allows expectant mothers to perform ultrasound scans at home in two ways: through a cradle that connects to a smartphone and transmits data, or under the remote guidance of a medical professional via telemedicine. The regulatory pathway approved by the U.S. Food and Drug Administration is among the agency’s most rigorous, requiring compliance with high standards of safety, quality, and clinical effectiveness.
“This FDA approval marks a significant milestone for the company and paves the way for commercial activity in the U.S., which we view as a key market with vast business potential,” said Dr. Elazar Sonnenschein, Pulsenmore’s founder and CEO. “The FDA’s decision affirms the scientific and clinical rigor of Pulsenmore’s technology and represents a leap forward in pregnancy monitoring, improving accessibility for expectant mothers while reducing the heavy burden on healthcare systems.”
According to the U.S. Centers for Disease Control and Prevention, about 3.6 million births occur each year in the United States, and Pulsenmore expects its product to be covered under existing insurance plans.
In many parts of the country, women struggle to access adequate prenatal and obstetric care due to staff shortages, forcing some to travel long distances for routine monitoring. High-risk pregnancies often require multiple in-person checkups each week. Pulsenmore’s device aims to reduce those visits by enabling proactive remote monitoring.
Prof. Israel Meizner, one of Israel’s most senior obstetrics and ultrasound specialists and Pulsenmore’s chief medical officer, said the technology represents a global breakthrough in fetal monitoring. “It allows care and consultation without physical or time limitations,” he said, “enabling flexible, accessible, and equitable medicine that can even be lifesaving, especially for women in remote or isolated areas.”
Dr. Sonnenschein, who holds a Ph.D. in electrical engineering and specializes in ultrasound imaging, previously founded Medigus, another medical imaging company. In Israel, Pulsenmore’s device is already in use under a strategic agreement with Clalit Health Services, which provides thousands of units to pregnant women from week 14 of pregnancy. The device, manufactured in Israel, has already supported 150,000 home scans and costs about NIS 350 (roughly $90) through Clalit’s supplementary insurance. The company also holds marketing approvals in Europe, Australia, and Brazil.
Founded in 2014 and listed on the Tel Aviv Stock Exchange in 2021 at a valuation of NIS 670 million (about $175 million), Pulsenmore’s stock later plunged more than 85%. After Sunday’s rally, the company’s market capitalization now stands at approximately NIS 233 million (around $61 million).