Prenatal ultrasounds are a routine part of pregnancy care, but they don’t always catch everything. In fact, standard scans can miss a significant number of fetal abnormalities. A newly approved artificial intelligence tool in the United States is now aiming to change that by helping doctors spot potential problems earlier and more reliably.
A Smarter Set of Eyes for Ultrasounds
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 while a scan is being performed.
As the ultrasound captures images, the AI immediately checks their quality and alerts the clinician if adjustments are needed to get a clearer view. It also confirms whether all required parts of the fetus are visible and flags anything missing from the scan. By comparing images against patterns drawn from global medical data, the system can highlight potential concerns such as heart, limb or organ abnormalities.
Once the scan is complete, the software compiles its findings into a report that doctors can review, helping streamline both diagnosis and documentation. BioticsAI says this process can save clinicians around eight minutes per patient.
Why Better Detection Matters
Congenital anomalies remain a major challenge in prenatal care. According to the European Commission, serious birth defects occur in roughly 24 out of every 10,000 births across Europe. Research shows that many of these conditions are still missed during routine scans.
A large review by Cochrane, which analysed data from more than seven million pregnancies, found that an early ultrasound between 11 and 14 weeks detects just 38 percent of birth defects. A later scan at around 18 to 24 weeks improves detection to 51 percent. When both scans are combined, detection rates rise significantly, reaching 84 percent.
Tools like BioticsAI’s software aim to reduce the number of missed diagnoses by providing consistent, real-time support during scans, especially in busy clinical settings.
A Growing Role for AI in Prenatal Care
The FDA’s clearance confirms that the software meets medical device standards and can be safely integrated into clinical workflows. It also reflects a wider shift toward using artificial intelligence to support decision-making in healthcare.
Similar technologies are already gaining ground elsewhere. In Europe, companies such as France-based Diagnoly and Sonio Detect have received approval for AI-assisted prenatal ultrasound tools. These systems help automatically identify fetal structures and detect potential heart conditions.
As AI continues to develop, its role in prenatal screening is expected to expand, offering doctors an extra layer of support and giving expectant parents greater confidence that potential issues are being caught as early as possible.
