Software that reads CT scans of the abdomen and pelvis can now flag 10 more kinds of urgent findings for US hospitals. The startup a2z Radiology AI announced the FDA clearance for its a2z-Abdo-Triage on September 21.
A busy hospital can have a long list of scans waiting to be read. Triage software, which sorts cases by urgency, looks at each scan as it arrives and moves likely emergencies up the list. The radiologist still reads every scan and makes every diagnosis.
From seven findings to 17
The new clearance covers findings such as a kidney stone that blocks the flow of urine, appendicitis, an abscess, internal bleeding and injuries to the spleen, liver and kidneys. Several of them are typical after accidents.
The company's earlier product, a2z-Unified-Triage, was cleared for seven findings. Together the two devices now cover 17. The software works on scans taken with or without contrast dye, in adults aged 22 and older.
The FDA also gave a2z-Abdo-Triage Breakthrough Device designation, a status for devices that may offer a better option for serious conditions.
Missing numbers
The announcement does not say how often the software is right or how much time it saves in practice. Those numbers decide whether a triage tool helps or just adds alerts.
Clearance means the FDA accepted the company's evidence for these uses. Independent data from hospitals is not yet public.
