Prenatal ultrasounds are a critical tool for monitoring a baby’s development, but studies show they miss up to half of fetal abnormalities. A new AI-powered software recently approved by the U.S. Food and Drug Administration (FDA) could help doctors spot problems earlier and more accurately.
How the AI Enhances Scans
The software, developed by American start-up BioticsAI, works alongside existing ultrasound machines. It analyzes images in real-time, checks their quality, and suggests adjustments for a clearer view. The AI ensures all parts of the baby are visible, flags any missing elements, and identifies potential issues such as heart or limb defects. After the scan, it produces a comprehensive report that doctors can review immediately, potentially saving around eight minutes per patient in documentation.
Why Better Detection Matters
Congenital anomalies affect roughly 24 out of every 10,000 births in Europe. A large Cochrane review covering over seven million pregnancies found that an early scan (11–14 weeks) detects only 38% of birth defects, while a mid-pregnancy scan (18–24 weeks) detects 51%. Performing both scans raises detection to 84%, leaving a gap that AI technology could help fill.
Global Moves Toward AI in Prenatal Care
Europe is also embracing AI in prenatal care. French companies Diagnoly and Sonio Detect have developed tools approved for clinical use that automatically assess fetal structures and heart health. With AI helping doctors catch anomalies earlier, parents and healthcare providers can have greater confidence in monitoring healthy fetal development.

