Israeli home ultrasound device wins FDA approval, set to expand prenatal care access

An Israeli-developed handheld ultrasound device that allows pregnant women to perform scans from home has received approval from the US Food and Drug Administration, marking a milestone in prenatal care technology.

The device, Pulsenmore, connects to a smartphone and guides expectant mothers step by step through an ultrasound exam using a dedicated app. In some cases, physicians can follow the scan live and provide real-time guidance remotely.

For Mor, who is six months pregnant, the experience offered reassurance during a period often marked by both excitement and anxiety. After completing the scan herself, she was able to see her baby and confirm that everything was progressing normally.

Pulsenmore’s developers say the goal is to improve access to care, reduce inequalities, and provide peace of mind between in-person medical visits. The technology is designed to be used safely by non-medical users with guided instructions.

FDA approval followed a large clinical trial conducted across four major US hospitals. The study demonstrated that pregnant women could perform reliable ultrasounds at home when supported by the device’s guidance system.

Professor Eran Hadar, head of the fetal-maternal medicine department at Rabin Medical Center in Petah Tikva, said more than 2,000 patients are already using Pulsenmore under medical supervision. He noted the device is especially helpful for women requiring frequent monitoring.

The technology could be particularly impactful in the United States, where around 35% of counties are classified as medical deserts, often forcing pregnant women to travel hours for basic care. Pulsenmore is currently used by about 20,000 women worldwide, including in Israel, Brazil, Australia, and Europe, and is expected to launch in the US in 2026.