FDA clears radiology AI triage tool to check for 10 additional findings on CT scans
The U.S. Food and Drug Administration has cleared a radiology artificial intelligence tool to check for 10 additional findings on abdomen-pelvis CT scans.
Imaging startup a2z Radiology AI Inc. on Monday touted the regulatory approval, which applies to its Abdo-Triage product. This expands the AI software’s range of suspected findings it can flag for clinical review up to 17, building on a previous clearance earned in late 2025.
Found in 2024, the Boston-based company says it’s building the “intelligence layer for medical imaging,” hoping to make radiologist interpretations “accessible on demand.”
“Care teams need support that reflects the range of cases they see,” Samir Rajpurkar, co-founder and CEO of a2z Radiology AI, said in a statement Sept. 21. “We’re building a platform around that need. This clearance extends the range of clinically important findings we can flag on CT scans, bringing us closer to our goal of helping teams focus their attention where it is needed.”
The software works by analyzing CT scans (with or without contrast) in adults ages 22 and older. It flags and then communicates any suspected positive cases, helping radiology teams prioritize studies for further review. Abdo-Triage works in concert with the radiologist’s interpretation, allowing docs to review the full scan and make their own clinical judgements. The product also has received the FDA’s Breakthrough Device designation, aimed at accelerating access to clinical innovations.
The 10 newly cleared indications include obstructing ureteral stone, hydroureter, retroperitoneal hematoma, large volume ascites, acute appendicitis, intra-abdominopelvic abscess, hemoperitoneum or complex free fluid, splenic traumatic injury, hepatic traumatic injury and renal traumatic injury. This is on top of the seven previously cleared findings: acute cholecystitis, acute pancreatitis, unruptured abdominal aortic aneurysm, acute diverticulitis, free air, hydronephrosis and small bowel obstruction.
Pranav Rajpurkar, PhD, a Harvard Medical School professor and AI entrepreneur, founded the firm alongside his father Samir Rajpurkar, a technology industry veteran who also launched the Leap Fintech software consulting firm in Dubai. The younger Rajpurkar—a Radiology Business Forty Under 40 winner—teaches biomedical informatics at Harvard, with his research focused on AI algorithm development and clinical decision-making. Pranav has written numerous articles on imaging, including recently in Radiology on the need for new “generalist” AI models that move beyond single tasks.
A2z also previously scored $5 million in investor funding last year, coinciding with its other FDA clearance.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.