A new AI tool may soon give doctors a sharper edge in detecting fetal abnormalities, addressing a major limitation in traditional prenatal ultrasounds that can miss up to half of potential issues.
Smarter Scans in Real Time
The software, developed by U.S. start-up BioticsAI, has received FDA clearance for clinical use. Designed to work alongside existing ultrasound machines, it analyzes images as they are captured, helping clinicians identify malformations during routine pregnancy scans.
Prenatal ultrasounds are a standard part of monitoring fetal development, but despite their widespread use, many abnormalities—affecting organs or limbs—can go unnoticed. This AI tool adds an extra layer of detection, ensuring doctors don’t miss crucial details.
How the Technology Works
When an ultrasound image is captured, the software instantly evaluates its quality, suggesting adjustments for a clearer view. It also scans the image to confirm that all key parts of the fetus are visible, flagging any missing elements.
Drawing on patterns from a large international dataset, the AI can detect anomalies such as heart defects or limb malformations and generate a comprehensive report for the doctor to review. Developers say the system can save about eight minutes per patient by reducing documentation time.
The FDA approval confirms the software meets medical device standards and can be safely integrated into existing ultrasound workflows.
Tackling Gaps in Prenatal Screening
Congenital anomalies affect roughly 24 out of every 10,000 births in Europe, according to European Commission data. Cochrane’s review of over seven million pregnancies highlights the limitations of current ultrasound screening: a single early scan detects only 38 percent of birth defects, while a mid-pregnancy scan identifies 51 percent. Combining both scans improves detection to 84 percent—but gaps remain.
Europe is also exploring AI-based solutions. French companies Diagnoly and Sonio Detect have developed similar tools that automatically detect fetal structures and heart issues, demonstrating the growing role of artificial intelligence in improving prenatal care and giving families greater confidence in their baby’s health.
