Israeli medical device company Pulsenmore has achieved a significant regulatory milestone with FDA marketing approval for its home-use ultrasound device designed for pregnant women. The approval represents the first time the FDA has cleared an ultrasound device explicitly intended for home use, both with remote professional guidance and independent patient operation.
Breakthrough Regulatory Pathway
The FDA granted approval through the 510k de novo pathway, indicating no precedent exists for such a product in the US market. "This means that there is no precedent for such a product in the US, and anyone who wants to enter the category now will have to compare themselves to a control group similar to the one we were asked to compare our treatment to," explained Dr. Elazar Sonnenschein, Pulsenmore's CEO.
The regulatory pathway represents one of the FDA's most rigorous approval processes, requiring compliance with high standards of safety, quality, and clinical effectiveness. Sonnenschein emphasized the significance of the FDA's labeling, which "explicitly states that it is intended for home use, both with remote professional guidance - but also with digital guidance by the patient herself, without a professional."
Technology and Market Impact
The Pulsenmore ES device operates through two distinct modes: a cradle that connects to a smartphone and transmits data, or under remote guidance of medical professionals via telemedicine. The technology addresses critical gaps in prenatal care accessibility, particularly relevant given that approximately 3.6 million births occur annually in the United States according to the CDC.
"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," the company noted. High-risk pregnancies often require multiple weekly in-person checkups, a burden the device aims to reduce through proactive remote monitoring.
Clinical Leadership and Global Experience
Prof. Israel Meizner, one of Israel's most senior obstetrics and ultrasound specialists serving as Pulsenmore's chief medical officer, described the technology as "a global breakthrough in fetal monitoring." He emphasized that "it allows care and consultation without physical or time limitations, enabling flexible, accessible, and equitable medicine that can even be lifesaving, especially for women in remote or isolated areas."
The device has demonstrated substantial real-world application in Israel, where it operates under a strategic agreement with Clalit Health Services. The Israeli implementation has supported 150,000 home scans, with the device provided to pregnant women from week 14 of pregnancy at a cost of approximately NIS 350 (roughly $90) through supplementary insurance coverage.
Market Response and Commercial Strategy
Following the FDA announcement, Pulsenmore's shares surged 33% on the Tel Aviv Stock Exchange, reflecting investor confidence in the US market opportunity. The company had a market capitalization of NIS 195 million before the trading session.
Pulsenmore expects the device to be covered under existing US insurance plans and is preparing for independent market entry while remaining open to distributor partnerships. The company is currently engaged in discussions with potential distribution partners of various sizes.
The FDA approval comes after previous challenges, including the termination of a strategic marketing agreement with medical device giant GE, partly due to delays in obtaining FDA approval. Dr. Sonnenschein noted that clinical trial implementation during the COVID pandemic initially facilitated patient recruitment for remote medicine studies, though the pace slowed as pandemic conditions normalized.
Global Regulatory Portfolio
Beyond the US approval, Pulsenmore holds marketing approvals in Europe, Australia, and Brazil, positioning the company for broader international expansion. The device, manufactured in Israel, represents the work of Dr. Sonnenschein, who holds a Ph.D. in electrical engineering specializing in ultrasound imaging and previously founded medical imaging company Medigus.
