Prenatal ultrasounds save lives by detecting potential issues in developing babies, but traditional scans can miss up to half of fetal abnormalities. Now, a new AI-powered tool cleared by the U.S. Food and Drug Administration promises to boost accuracy and help doctors spot problems earlier.
How the AI Works
Developed by American start-up BioticsAI, the software integrates with existing ultrasound machines and analyses images in real-time. It checks the quality of each scan, suggests adjustments for a clearer view, and ensures every part of the baby is visible. Using patterns from global datasets, the AI flags potential anomalies, such as heart or limb defects, and generates a report doctors can review immediately. The developers say it could save clinicians around eight minutes per patient by streamlining documentation.
Why Detection Matters
Congenital anomalies affect roughly 24 out of every 10,000 births in Europe. Research from Cochrane, reviewing more than seven million pregnancies, shows that early scans (11–14 weeks) catch just 38% of birth defects, while mid-pregnancy scans (18–24 weeks) detect 51%. When both scans are done, detection rises to 84%, leaving a gap that AI could help fill.
AI Innovation in Europe
Similar AI tools are emerging worldwide. French companies Diagnoly and Sonio Detect have received approval for prenatal use, helping doctors automatically detect fetal structures and heart issues. With these innovations, AI is increasingly becoming a vital partner in prenatal care, giving families and healthcare providers more confidence in monitoring healthy development.
