Boston-based start-up a2z Radiology AI has received U.S. Food and Drug Administration (FDA) clearance for a2z-Abdo-Triage, an AI device that flags 10 findings on abdominopelvic CT scans to help radiology teams prioritize studies for review.
The software analyzes abdominopelvic CT images acquired with or without intravenous contrast in adults 22 and older. 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
Renal traumatic injury
The device joins the company's a2z-Unified-Triage platform, which covers seven other findings, including acute cholecystitis, acute pancreatitis, and small bowel obstruction, bringing the firm's total to 17 FDA-cleared findings across both products. a2z-Abdo-Triage has also received FDA Breakthrough Device designation, the company noted.
