Israeli femtech company Pulsenmore has received De Novo clearance from the U.S. Food and Drug Administration (FDA)—one of the most prestigious and demanding approvals in global medtech—for its at-home ultrasound system, Pulsenmore ES, designed for pregnant women. The authorization paves the way for the company’s entry into the vast U.S. maternal-care market, with roughly 3.6 million births annually, and cements its status as a world pioneer in femtech and telemedicine.

The Pulsenmore ES system enables expectant mothers to perform ultrasound scans at home using a smart adapter that connects to a mobile phone, guided by an interactive app or in real time under a physician’s supervision. The images are securely transmitted to the clinician, who can interpret them and conduct remote follow-up. The clearance follows a multi-center clinical trial across four leading medical institutions—Mount Sinai, Brigham and Women’s Hospital, the University of Florida, and the Center for Women’s Health in Los Angeles—which confirmed that women can safely and accurately perform home scans under medical oversight.

According to the company, the device will be eligible for reimbursement under existing U.S. billing codes (Limited Ultrasound), allowing an immediate commercial launch without additional regulatory procedures.

A Custom ASIC and Robotic Manufacturing Line

Pulsenmore’s technology is built around a proprietary ASIC chip, co-developed with Japan’s Seiko, which offloads image processing to the smartphone and dramatically reduces device cost. The company also developed a robotic manufacturing process for producing the piezoelectric transducers—the ultrasound’s core components—enabling high-precision, low-cost, and almost fully automated production.
The ES system features 64 transmit-and-receive elements and uses materials optimized for high-resolution fetal monitoring, capable of detecting details within just a few centimeters.

In June 2023, Techtime reported that Pulsenmore plans to establish a fully automated production line in Israel with a capacity of up to one million units per year. The line will include robotic crystal growth, element cutting, and precision assembly of transducers—part of a broader effort to scale for global demand and reduce costs to a consumer-level price point.

Dr. Elazar Sonnenchein, Pulsenmore’s founder and CEO—and former Head of Medical Devices at Sony Europe—said the FDA approval marks a pivotal transition for the company: “The FDA is validating not only our technology but also our vision of accessible medicine—high-quality pregnancy monitoring anytime, anywhere.”

With the new clearance and its advanced manufacturing infrastructure, Pulsenmore is positioning itself as a global leader in the digital and mobile ultrasound revolution.