The US Food and Drug Administration (FDA) has granted 510(k) clearance to DeepEcho鈥檚 foetal ultrasound analysis platform.
This decision allows the company to enhance prenatal care and expand access to this technology.
Utilising deep learning algorithms, the AI-powered solution automates real-time detection of foetal ultrasound views, aiding healthcare professionals by improving diagnostic accuracy and image evaluations.
The platform’s approach includes segmentation of structures for foetal biometry and amniotic fluid volume evaluation, offering a standardised analysis of foetal structures.
DeepEcho focuses on foetal ultrasound diagnostics, with a presence across three continents: Europe, Africa, and the US.
The solution was developed by the company’s team, comprising AI scientists, physicians, and medical imaging experts.
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By GlobalDataDeepEcho chief medical officer and co-founder Dr Saad Slimani said: “This milestone underscores the power of combining AI with clinical expertise to solve some of the most critical problems in healthcare.
“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.”
DeepEcho noted that it is creating next-generation solutions that utilise AI to detect biomarkers.
These advancements aim to facilitate the early prediction of complex conditions like preeclampsia, a major cause of maternal and neonatal morbidity and death.
DeepEcho CEO and co-founder Youssef Bouyakhf said: “Our FDA clearance is a pivotal achievement, validating the rigour of our technology and the quality and safety of our product at DeepEcho.
“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.”
