Boston — a2z Radiology AI Inc. announced that the U.S. Food and Drug Administration has cleared its a2z-Abdo-Triage software for 10 findings on abdomen-pelvis CT scans, expanding the company’s acute-care imaging portfolio to 17 findings across two FDA-cleared devices.
The newly cleared software analyzes abdominopelvic CT images acquired with or without intravenous contrast in adults age 22 and older. It flags suspected positive cases to help radiology teams prioritize studies for review.
The software is intended to work alongside standard image interpretation, with radiologists continuing to review the full scan and make clinical judgments. a2z-Abdo-Triage has also received FDA Breakthrough Device designation.
“Care teams need support that reflects the range of cases they see,” said Samir Rajpurkar, Co-Founder and CEO of a2z Radiology AI. “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 10 newly cleared findings are obstructing ureteral stone, hydroureter, retroperitoneal hematoma, large-volume ascites, acute appendicitis, intraabdominopelvic abscess, hemoperitoneum or complex free fluid, splenic traumatic injury, hepatic traumatic injury and renal traumatic injury.
The clearance builds on seven findings previously cleared for the company’s a2z-Unified-Triage device: acute cholecystitis, acute pancreatitis, unruptured abdominal aortic aneurysm, acute diverticulitis, free air, hydronephrosis and small bowel obstruction.
The company said its goal is to expand imaging coverage to help care teams identify studies that may require more timely attention.
