DeepEcho Reaches New Milestone With FDA 510(k) Clearance for AI-Powered Prenatal Imaging
NEW YORK— June 20, 2025
DeepEcho, an AI-first healthtech company revolutionizing maternal and fetal health, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its fetal ultrasound analysis platform.
This milestone marks a major step forward in DeepEcho’s mission to transform prenatal care and democratize access to quality fetal ultrasound.
DeepEcho’s AI solution leverages deep learning to automate real-time identification of fetal ultrasound views, enhancing diagnostic accuracy and efficiency for healthcare professionals.
Trained on one of the world’s largest fetal ultrasound datasets, the platform standardizes image acquisition and analysis —including fetal biometry and amniotic fluid volume assessment — ensuring more consistent and reproducible results.
With offices across the U.S., Europe, and Africa, DeepEcho aims to become a global leader in fetal ultrasound diagnostics.
Built by physicians, AI scientists, and imaging experts, the company’s technology addresses key clinical challenges — from workflow inefficiencies and diagnostic variability to workforce shortages in emerging markets.
“Our FDA clearance is a pivotal achievement, validating the rigor of our technology and the quality and safety of our product at DeepEcho” said Youssef Bouyakhf, co-founder and CEO of the company.
“We are extremely excited about the potential behind our current solution and the very ambitious plans we have for DeepEcho with more advanced features that we will bring to market in the near future”
“This milestone underscores the power of combining AI with clinical expertise to solve some of the most critical problems in healthcare,” added Dr. Saad Slimani, co-founder and Chief Medical Officer of DeepEcho.
“With this FDA clearance, we are one step closer to making early, accurate prenatal diagnosis universally accessible and helping clinicians deliver better outcomes for families.”
Looking ahead, DeepEcho is developing next-generation AI tools to identify novel biomarkers for earlier and more precise prediction of complex conditions such as preeclampsia, a leading cause of maternal and neonatal morbidity and mortality.
This innovation aims to enable earlier intervention and improve maternal-fetal outcomes globally.
Earning FDA clearance is only the beginning. DeepEcho continues to advance prenatal AI technology, driving progress toward earlier, smarter, and more equitable maternal and fetal healthcare worldwide.
About DeepEcho
DeepEcho is an AI-first healthtech company founded by AI and healthcare experts. Its mission is to revolutionize prenatal care by equipping clinicians with powerful, accessible tools to enhance fetal ultrasound diagnostics.
By leveraging one of the world’s largest fetal ultrasound datasets and state-of-the-art deep learning, DeepEcho is shaping the future of maternal-fetal health to ensure better outcomes for mothers and babies worldwide.Read the full press release on Newswire:
👉 https://www.newswire.com/news/deepecho-reaches-new-milestone-with-fda-510-k-clearance-for-ai-powered-22595093