Wednesday, November 5, 2025

Health and Wellness News: Israel's Pulsenmore gains FDA approval for at-home ultrasound device

Israel's Pulsenmore gains FDA approval for at-home ultrasound device

Pulsenmore’s FDA-approved home ultrasound device allows pregnant women to perform scans from home, revolutionizing pregnancy care in remote areas.

By Dr. Itay Gal, Jerusalem Post, Nov.3, 2025

https://www.jpost.com/health-and-wellness/pregnancy-and-birth/article-872512

The home ultrasound. Pregnancy monitoring even without going to the hospital (photo credit: Courtesy of Pulsenmore)

A revolution in pregnancy monitoring, Israeli company Pulsenmore, a pioneer in home ultrasound technology, has received official approval from the US FDA to market its Pulsenmore ES device, enabling pregnant women to perform home ultrasound scans.

The approval includes two modes of use: a scan guided by a mobile app, or a scan supervised by a doctor remotely as part of telemedicine.

The approval came after the company successfully completed a multi-center clinical study in the US, showing that pregnant women can safely and accurately perform home ultrasound scans under medical supervision.

The study was conducted at four leading medical institutions: Mount Sinai Hospital in New York, Brigham and Women's Hospital in Boston, the University of Florida, and the Fetal Medicine and Women's Ultrasound Center in Los Angeles.

In the US, approximately 3.6 million births occur annually, according to the Centers for Disease Control and Prevention (CDC).

Approximately 35% of US counties are considered "medical deserts," where there is a shortage of obstetricians and doctors, requiring women to travel long distances for basic care.

For women with high-risk pregnancies, who may need to attend multiple appointments per week, this is a heavy burden.

Pulsenmore estimates that the device will enable medical teams to monitor these pregnancies remotely, reducing in-person visits and improving the quality of care.

In the US, the reimbursement system is based on medical coding, and there are already active codes for ultrasound exams and telemedicine services. Therefore, following FDA approval, the product will be included under an existing code for limited ultrasound exams, and no new codes will be required.

Pulsenmore- Bringing ultrasounds home

A change in the game

Professor Alfred Abouhamed, Chairman of Pulsenmore’s Medical Advisory Board in the US, emphasized that this is a breakthrough, saying, "Pulsenmore's product changes the game in pregnancy monitoring, expanding ultrasound accessibility beyond the clinic. It allows doctors to monitor the condition of pregnant women in real time and make more accurate medical decisions."

Professor Israel Meizner, one of Israel's leading ultrasound experts, responded to the approval. He said, "Pulsenmore’s technology is a global revolution in fetal monitoring. It provides immediate, accessible, and equitable medical care, even in remote areas, and, in many cases, can save lives. This is an important step towards flexible, personalized medicine for women everywhere."