Health
FDA Clears AI Tool to Improve Detection of Fetal Abnormalities in Ultrasounds
A new artificial intelligence software designed to enhance prenatal ultrasound screenings has received clearance from the United States Food and Drug Administration (FDA), offering a potential boost to the detection of fetal abnormalities.
Developed by the American start-up BioticsAI, the tool integrates with existing ultrasound machines to analyze images in real time, highlighting potential issues during scans. Prenatal ultrasounds are widely used throughout pregnancy to identify potential problems in a developing fetus, including malformations in organs or limbs. Yet studies suggest that routine scans can miss a significant number of abnormalities.
According to research, a single early scan performed between 11 and 14 weeks of pregnancy detects only about 38 percent of birth defects. A mid-pregnancy scan, typically conducted between 18 and 24 weeks, identifies roughly 51 percent of abnormalities. When both scans are performed, detection rises to 84 percent, leaving a remaining gap in diagnosis.
BioticsAI’s software works by analyzing each fetal image as it is captured. It evaluates image quality, suggesting adjustments to ensure a clear view of the fetus, and checks whether all parts of the baby are visible. Using data patterns drawn from a global database, the system can detect anomalies, including heart or limb defects, and flag them for the doctor during the scan. After the examination, the software generates a report compiling all findings for clinical review.
Developers say the tool can also save healthcare professionals roughly eight minutes per patient in documentation time. The FDA’s clearance confirms that the software meets medical device performance standards and can be safely integrated into current ultrasound systems.
The approval comes amid ongoing challenges in prenatal care. In Europe, major congenital anomalies occur in about 23.9 per 10,000 births. AI-driven tools are emerging as a promising supplement to conventional scans. French companies Diagnoly and Sonio Detect have also received approval for AI-assisted ultrasound solutions, which automatically identify fetal structures and detect potential heart issues.
Experts say integrating AI into prenatal care could improve early detection rates and help doctors provide timely interventions or monitoring. Real-time feedback during scans ensures that images are complete and abnormalities are less likely to be missed.
BioticsAI’s FDA-cleared tool is expected to be rolled out in clinics across the United States, offering clinicians an additional layer of support in detecting congenital abnormalities. As AI technologies continue to expand in healthcare, prenatal care is emerging as a key area where machine learning can complement human expertise, improving outcomes for both mothers and babies.
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