#USA #FDA Approval #Ramat Gan #Pulsenmore #Prenatal Ultrasound

A New Frontier in Prenatal Care: Pulsenmore's Home Ultrasound Innovation

In a groundbreaking development for expectant mothers across the United States, Pulsenmore Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for its innovative home-use prenatal ultrasound device, the Pulsenmore ES. This pioneering platform is set to transform prenatal care by allowing mothers-to-be to conduct guided ultrasounds from the comfort of their homes, under the remote supervision of healthcare professionals.

This significant approval signals a new era in prenatal care, particularly at a time when access to obstetric services is becoming increasingly strained. According to recent data from the CDC, approximately 3.6 million births occur annually in the U.S., yet around 35% of counties are designated as maternity care deserts. Pulsenmore’s solution aims to bridge this gap by facilitating home-based self-scanning, which allows for clinical review and interpretation by physicians without the need for in-clinic visits.

The Pulsenmore ES device connects seamlessly to the patient's smartphone and utilizes an intuitive app that guides users step-by-step through the scanning process. This interactive feature ensures ease of use, even for those without prior ultrasound experience. Once the scans are completed, video clips are securely transmitted to designated healthcare providers for review via a dedicated dashboard, ensuring that professional oversight remains central to prenatal care.

Dr. Wulf Utian, a renowned expert in women's health, has praised this advancement as a long-awaited leap forward in obstetrical care. The Pulsenmore ES not only alleviates the burden of unnecessary in-clinic visits that can heighten anxiety for expectant mothers, but it also improves the triage process within healthcare systems. This innovation facilitates a more streamlined approach to maternal health, benefiting patients and clinicians alike.

While the Pulsenmore ES is a revolutionary tool for offering prenatal imaging, it does not replace traditional diagnostic or anatomical ultrasound examinations conducted in clinics. Instead, it complements existing workflows as advised by the American College of Obstetrics and Gynecology, advocating for tailored prenatal care approaches for pregnant individuals.

Dr. Alfred Abuhamad, Chairman of Pulsenmore's Medical Advisory Board, highlighted the transformative nature of this technology. He stated, "With FDA marketing authorization, Pulsenmore introduces a transformative model for prenatal care, extending ultrasound access beyond the clinic and redefining how we reach and monitor expectant mothers."

This groundbreaking technology has already garnered global recognition, as the Pulsenmore ES has been in use across health systems in Israel, Europe, Brazil, and Australia, successfully supporting over 200,000 patient scans with clinical interpretation. Key partnerships with organizations such as Clalit Health Services, one of the largest health maintenance organizations in the world, and Sheba Medical Center, consistently ranked among the top hospitals globally, underscore Pulsenmore's commitment to enhancing healthcare accessibility.

As Pulsenmore gears up for a phased launch in the U.S. in early 2026, in collaboration with prominent clinical institutions, the anticipation surrounding this new model for prenatal care continues to grow. Dr. Elazar Sonnenschein, CEO and founder of Pulsenmore, emphasized that this solution is designed to eliminate barriers caused by distance and capacity issues, enabling healthcare providers to maintain continual contact with their patients throughout pregnancy.

In conclusion, the Pulsenmore ES home ultrasound platform is more than just a device; it represents a significant step forward in making prenatal care more accessible, equitable, and efficient. Expectant mothers can look forward to a future where they have greater control over their prenatal health, ensuring healthier beginnings for both themselves and their babies.

Contact Information:
Mira Altmark-Sofer
Vice President, Global Marketing, Pulsenmore Ltd.
Tel: +972-50-591-1212
Email: [email protected]

For further details, visit Pulsenmore's website.