DeepEcho Receives FDA Breakthrough Device Designation for Blind Sweep Prenatal Ultrasound Platform

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Expanding access to timely, high-quality prenatal imaging through scalable ultrasound that reduces dependence on highly specialized operators across diverse care settings worldwide

NEW YORK CITY, NY / ACCESS Newswire / March 25, 2026 / DeepEcho Inc. today announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its DEEPECHO Blind Sweep Platform, marking a significant step toward reimagining how prenatal ultrasound is delivered at scale.

Around the world, millions of pregnancies progress without access to timely, high-quality ultrasound-limiting early detection of complications and contributing to preventable risks for mothers and babies. DeepEcho is working to change that paradigm by transforming ultrasound into a more accessible, standardized, and scalable tool for frontline care.

The DEEPECHO Blind Sweep Platform leverages software-driven analysis of B-mode ultrasound videos acquired through simple, protocol-based sweeps using handheld or cart-based devices. By guiding acquisition and automating key measurements-including fetal presentation, placental location, amniotic fluid, fetal heart rate, gestational age, and estimated fetal weight-the platform helps bring consistency to a process traditionally dependent on highly specialized expertise.

The FDA's Breakthrough Device Designation is reserved for technologies that may offer substantial improvements in the diagnosis or treatment of serious conditions. It also enables a more collaborative and accelerated engagement with the FDA as the technology advances toward potential authorization.

"We are building tools that support clinicians-helping extend their reach, reduce variability in exams, and ensure that more patients can benefit from high-quality assessments, no matter where they are," said Saad Slimani, M.D., Chief Medical Officer and Co-founder of DeepEcho.

Designed for use by healthcare personnel trained in ultrasound acquisition, with interpretation performed by licensed clinicians, the platform introduces a repeatable and scalable approach to imaging. Its standardized workflows are intended to reduce variability, expand access beyond traditional settings, and support clinicians in delivering reliable assessments across care environments everywhere.

DeepEcho will continue working closely with the FDA to advance clinical validation and define the regulatory pathway forward, with a long-term vision of democratizing access to essential prenatal imaging and improving outcomes for mothers and babies worldwide.

Media Contact:

DeepEcho

Email: [email protected]

SOURCE: DeepEcho