Pulsenmore Granted FDA Authorization for At-Home Prenatal Ultrasound, Expanding Access to U.S. Mothers
LONDON – November 3, 2025 – Pulsenmore Ltd.announced today it has received De Novo marketing authorization from the U.S. Food and drug Governance (FDA) for its home-use prenatal ultrasound device. This landmark approval paves the way for a new hybrid prenatal care model,offering expectant mothers greater convenience and control over their prenatal monitoring,and possibly improving access to care,particularly in underserved communities.
The FDA’s authorization recognizes Pulsenmore’s technology as a novel approach to prenatal care, allowing for earlier detection of potential complications and fostering a stronger connection between mothers and their developing babies. The device supports hybrid prenatal care models across multiple global health systems,integrating seamlessly with existing clinical workflows. This development addresses a critical need for more accessible and affordable prenatal imaging, potentially reducing disparities in maternal health outcomes.
Pulsenmore’s device enables expectant mothers to perform ultrasound scans in the comfort of their homes, transmitting images to their healthcare providers for review. The company states this capability complements conventional in-clinic visits,offering a more comprehensive and continuous monitoring experience.
“This is a pivotal moment for prenatal care,” said Mira Altmark-Sofer, Vice President, Global Marketing at Pulsenmore Ltd. “Our technology empowers women to take an active role in their pregnancy journey while ensuring their healthcare providers have the data they need to deliver the best possible care.”
Further information about Pulsenmore and its technology can be found at www.pulsenmore.com.
Media Contact:
Mira Altmark-Sofer
Vice President, Global Marketing, Pulsenmore Ltd.
Tel: +972-50-591-1212
Email: [email protected]
