A breakthrough AI tool cleared by the U.S. FDA could change the way doctors detect fetal abnormalities, helping close the gap left by traditional ultrasounds. Developed by the start-up BioticsAI, the software works with existing ultrasound machines, analysing images in real-time and flagging potential issues during pregnancy scans.
Smarter Ultrasounds for Every Scan
Prenatal ultrasounds are a standard part of pregnancy care, but up to half of fetal abnormalities can go unnoticed. BioticsAI’s software instantly evaluates each captured image, checking for quality, suggesting adjustments, and ensuring all key parts of the fetus are visible. Using data patterns from around the world, it can spot anomalies like heart defects or limb malformations and generates a comprehensive report for the doctor. The tool also reduces administrative work, saving clinicians roughly eight minutes per patient.
Addressing Missed Diagnoses
Congenital anomalies remain a significant concern, affecting about 24 out of every 10,000 births in Europe. A Cochrane review of over seven million pregnancies found that early ultrasounds (11–14 weeks) detect just 38% of birth defects, while mid-pregnancy scans (18–24 weeks) catch 51%. Combined, detection rises to 84%, but some conditions still go unnoticed, highlighting the need for smarter screening tools.
AI Expands Across Borders
Europe is embracing similar innovations. French companies Diagnoly and Sonio Detect have also received approval for AI-assisted prenatal scans, helping clinicians automatically detect baby structures and heart issues. With these AI advancements, doctors can identify problems earlier and provide families with more accurate guidance, marking a significant step forward in prenatal care worldwide.
