FDA clears a2z Radiology AI triage tool for 10 more CT findings
a2z Radiology AI has won FDA clearance for its a2z-Abdo-Triage software covering 10 findings on abdomen-pelvis CT, taking its portfolio to 17 findings across two devices.
a2z Radiology AI has won US Food and Drug Administration clearance for its a2z-Abdo-Triage software, covering 10 findings on abdomen-pelvis CT scans.
The Boston-based company announced the clearance this week, expanding its portfolio to 17 findings across two FDA-cleared devices — the 10 new findings plus seven previously cleared for its a2z-Unified-Triage device.
The software flags and communicates suspected positive cases to help radiology teams prioritise studies for review. It analyses images taken with or without intravenous contrast in adults aged 22 and older, and works alongside standard interpretation — radiologists continue to review the full scan and make all clinical judgments. a2z-Abdo-Triage has also received FDA Breakthrough Device designation.
The 10 newly cleared findings include acute appendicitis, obstructing ureteral stone, retroperitoneal hematoma, large-volume ascites and traumatic injuries to the spleen, liver and kidneys. The seven previously cleared findings include acute cholecystitis, acute pancreatitis, hydronephrosis and small bowel obstruction.
“Care teams need support that reflects the range of cases they see,” said Samir Rajpurkar, the company’s co-founder and chief executive. “This clearance extends the range of clinically important findings we can flag on CT scans.”
a2z Radiology AI was co-founded by Harvard Medical School biomedical informatics associate professor Pranav Rajpurkar and technology entrepreneur Samir Rajpurkar, and is backed by Khosla Ventures and SeaX Ventures.
Sources
- Business Wire (company release): “a2z Radiology AI Expands Acute Care Suite with 10 Newly Cleared Findings” — https://www.businesswire.com/news/home/20260920727339/en/a2z-Radiology-AI-Expands-Acute-Care-Suite-with-10-Newly-Cleared-Findings
- Boston Life Sciences Times: “a2z Radiology AI Wins FDA Clearance for 10 Additional CT Findings” — https://bostonlifesciencestimes.com/2026/09/a2z-radiology-ai-wins-fda-clearance-for-10-additional-ct-findings/
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