Prenatal ultrasounds have long been a cornerstone of pregnancy care, but they don’t catch everything. In fact, up to half of fetal abnormalities can be missed. A newly approved artificial intelligence tool in the United States aims to change that by giving doctors extra eyes during routine scans.
A Smarter Set of Eyes in the Scan Room
The US Food and Drug Administration has cleared an AI-powered ultrasound assistant developed by American start-up BioticsAI for clinical use. The software works alongside existing ultrasound machines, analysing images in real time as scans are performed.
Its goal is simple: help clinicians spot potential problems earlier and more reliably. During a scan, the AI reviews each image as it appears, checks whether the picture quality is good enough and suggests adjustments if something needs to be repositioned. It also ensures that all key parts of the fetus are visible, alerting clinicians if anything is missing from the frame.
Spotting Problems Earlier
By drawing on patterns learned from large global datasets, the system can flag potential abnormalities, including issues with the heart or limbs. Once the scan is complete, it automatically generates a summary report that doctors can review, cutting down on paperwork and saving an estimated eight minutes per patient.
The FDA’s clearance means the software meets safety and performance standards and can be used as a regulated medical device within existing hospital systems.
Why Better Detection Matters
Congenital abnormalities remain a significant challenge in prenatal care. Across Europe, nearly 24 major birth defects occur for every 10,000 births, according to European Commission data. Research from Cochrane, which analysed more than seven million pregnancies, shows the limits of standard ultrasound screening: early scans detect just 38 percent of defects, while mid-pregnancy scans find about 51 percent. Using both improves detection, but gaps remain.
AI tools like BioticsAI’s are designed to help close those gaps. Similar technologies are already emerging in Europe, with French companies such as Diagnoly and Sonio Detect gaining approval for AI-assisted prenatal scans that automatically identify fetal structures and heart conditions.
Together, these developments signal a shift toward more accurate, efficient and supportive prenatal screening — one where technology helps clinicians catch what the human eye might miss.
