FDA Clears AI-Powered Triage Software for 10 Findings on Abdominopelvic CT

The Food and Drug Administration (FDA) has granted 510(k) clearance to a2z-Abdo-Triage for adjunctive AI detection and triage of 10 findings on abdominopelvic computed tomography (CT) scans.

The a2z-Abdo-Triage software, which has also garnered a breakthrough device designation from the FDA, can be utilized to facilitate triage and detection for the following newly cleared findings: abdominopelvic CT findings: acute appendicitis, hemoperitoneum or complex free fluid, hepatic traumatic injury, hydroureter, intraabdominopelvic abscess, large volume ascites, renal traumatic injury, retroperitoneal injury, splenic traumatic injury and ureteral stone.

Flagging suspected cases for priority review by radiologists, the a2z-Abdo-Triage software can be utilized on abdominopelvic CT scans obtained with or without contrast, according to a2z Radiology AI, the developer of the software.

“Care teams need support that reflects the range of cases they see,” said Samir Rajpurkar, the 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.”