A new artificial intelligence tool cleared by the U.S. Food and Drug Administration could help doctors catch fetal abnormalities that standard ultrasounds often miss. Developed by the American start-up BioticsAI, the software works with existing ultrasound machines to analyse images in real-time, flagging potential issues for clinicians during pregnancy scans.
Enhancing Ultrasound Accuracy
Prenatal ultrasounds are essential for monitoring a baby’s growth and development, but traditional scans can overlook a significant number of abnormalities. BioticsAI’s software instantly evaluates each image, checking its quality and suggesting adjustments for a clearer view. It also ensures that all key parts of the fetus are visible, highlighting any missing areas for further examination.
Using patterns derived from global data, the AI can detect possible problems such as heart or limb defects. After the scan, it produces a detailed report summarizing its findings, giving doctors an extra layer of insight. Developers estimate the tool can save around eight minutes per patient by reducing documentation time.
Tackling Gaps in Prenatal Care
Congenital anomalies remain a serious concern, affecting roughly 24 out of every 10,000 births in Europe. A major review by Cochrane, examining over seven million pregnancies, found that a single early ultrasound (11–14 weeks) detects only 38% of birth defects. Mid-pregnancy scans (18–24 weeks) catch 51%, and performing both raises detection to 84%—still leaving some conditions undetected.
AI Solutions Are Expanding Globally
Europe is also embracing AI to improve prenatal care. French companies Diagnoly and Sonio Detect have developed similar software approved for use in detecting fetal structures and heart conditions automatically. With tools like these, doctors can spot abnormalities earlier and provide families with more accurate and timely guidance, potentially transforming prenatal care worldwide.

