Prenatal ultrasounds are a routine part of pregnancy care, yet they still miss a significant number of fetal abnormalities. Now, a newly approved artificial intelligence tool could help doctors spot potential problems earlier and more accurately.
AI Joins the Ultrasound Room
The US Food and Drug Administration has cleared a new AI-powered software developed by American start-up BioticsAI for clinical use. The system works alongside existing ultrasound machines, analysing images in real time as scans are performed.
Its goal is simple but ambitious: to help doctors identify fetal abnormalities that might otherwise go unnoticed. Using large datasets drawn from global imaging patterns, the software can flag potential concerns such as heart defects or limb abnormalities while the scan is still in progress.
How the Technology Assists Doctors
As an ultrasound image is captured, the AI immediately checks its quality and suggests adjustments if the view isn’t clear enough. It also verifies whether all required parts of the fetus are visible and alerts clinicians if something appears to be missing from the scan.
Beyond image quality, the software analyses anatomical structures for signs of malformation. After the scan, it produces a detailed report that brings all its findings together, giving doctors a clearer picture to review. BioticsAI says the system can save clinicians up to eight minutes per patient by reducing the time spent on documentation.
Why Better Detection Matters
Congenital abnormalities remain relatively common, occurring in nearly 24 out of every 10,000 births across Europe. Research shows that routine ultrasound screening still has limitations. A major review of studies covering more than seven million pregnancies found that early scans detect just 38 percent of birth defects, while mid-pregnancy scans catch about half. Using both increases detection significantly, but gaps remain.
AI is increasingly being seen as a way to close those gaps. Similar tools are already in use in Europe, with companies like France’s Diagnoly and Sonio Detect developing approved systems that automatically identify fetal structures and heart issues.
With FDA clearance now secured, BioticsAI’s software marks another step toward more reliable prenatal screening — and the possibility of giving expectant parents and doctors clearer answers, sooner.
