a2z Radiology AI receives FDA clearance for abdomen-pelvis CT device

The a2z-Unified-Triage device is designed to simultaneously flag and prioritise seven urgent findings on abdomen-pelvis CT scans. 

a2z Radiology AI has secured approval from the US Food and Drug Administration (FDA) for its a2z-Unified-Triage, a multi-condition triage system for abdomen-pelvis CT scans.

The device is designed to simultaneously flag and prioritise seven urgent findings on these CT scans.

It covers seven major acute conditions, including small bowel obstruction, acute pancreatitis, acute cholecystitis, acute diverticulitis, free air, hydronephrosis, and unruptured abdominal aortic aneurysm, in one integration.

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According to a2z Radiology AI, this is claimed to be the first single device cleared in the US to triage multiple urgent conditions on abdomen-pelvis CTs in one pass. 

a2z Radiology AI co-founder and Harvard Medical School associate professor Pranav Rajpurkar said: “We set out to build a generalist system that could scale across conditions.

“We are starting with high-consequence acute conditions, cases where rapid triage can have the greatest immediate impact on patient care.”

According to the company, more than 20 million abdomen-pelvis CT scans are conducted annually in the US.

With rising case volumes, the a2z-Unified-Triage system is said to flag suspected emergencies and move them to the top of radiology worklists within minutes to ensure quick care for patients whose condition is critical.

a2z Radiology AI co-founder and CEO Samir Rajpurkar said: “For five of these seven conditions, we’re bringing AI triage to the US market for the first time. And we’re not stopping at seven. There’s still a lot of scaling ahead.”

The company built the AI-assisted a2z-Unified-Triage for real-world radiology workflows. It is also in the process of developing advanced research prototypes.

Extending beyond urgent triage, these prototypes explore comprehensive radiology AI across several conditions and anatomies.

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