
23 Oct 2026
FDA cleared Coreline Soft's AI that measures the aorta from a routine chest CT
Coreline Soft said on Friday, Oct. 23, 2026, that the FDA cleared AVIEW Aorta Metrics, AI software that automatically segments the aorta on chest CT and measures its diameter zone by zone.
Measuring an aorta by hand is fiddly, and an enlarged one is the kind of thing that's easy to miss when a radiologist is looking at the scan for a different reason. Software that measures it automatically, every time, on scans that already exist is the unglamorous, very useful side of medical AI. The catch with opportunistic screening, extra findings pulled from a scan ordered for something else, is always the same: more findings means more follow-ups, and somebody has to pay for and act on them. Thirteen FDA clearances says Coreline knows how to get through the door; the question is whether hospitals turn it on by default.
Coreline Soft said the FDA granted 510(k) clearance to AVIEW Aorta Metrics, number K260391. The agency cleared it on Oct. 16, 2026. The submission arrived Feb. 6, 2026. A 510(k) is the path the FDA uses when it decides a device is similar enough to one already allowed on the market. It is a device clearance. It is not a drug approval. This is Coreline Soft's 13th FDA 510(k). The date and the number are in the FDA's database. The count of 13 is the company's.
The software automatically segments the aorta on chest CT images. Segment, here, means it marks the aorta, the body's main artery, apart from the rest of the scan. It sorts the vessel into zones and measures the diameter of each one. It also shows a straightened curved planar reformation, a view that unbends the artery so a reader can look along it, plus cross-sections, a 3D view, and an analysis report. Those lines are Coreline Soft's.
Coreline Soft's U.S. chest CT lineup already includes AVIEW LCS and AVIEW Lung Nodule CAD, for lung cancer screening and for finding lung nodules, and AVIEW CAC, which measures coronary artery calcium, the chalky buildup in the heart's arteries, from a chest CT taken without contrast dye. This clearance adds the aortic measurement. Those lines are the company's.
The company is pitching what it calls opportunistic screening: extra findings pulled from CT scans a patient already had, without ordering a new scan, then sent into PACS and the rest of a radiology workflow. PACS is the system a hospital uses to store and view images. Coreline says that includes zero-click automation with INFINITT North America, meaning the measurement can run without someone starting it by hand. Those lines are Coreline Soft's.
Coreline Soft will be at RSNA 2026, the big radiology meeting, from Nov. 29 to Dec. 3 at McCormick Place in Chicago, at AI Showcase booth 5138. That line is the company's.
AVIEW Aorta Metrics is a measurement and analysis tool for clinicians. The announcement does not give an accuracy number or a clinical outcome. It does not say the software diagnoses an aneurysm, a dangerous bulge in the vessel, on its own. A radiologist still reads the scan.
The picture is Coreline Soft's own screen for AVIEW Aorta Metrics: a 3D aorta the software has marked off, a straightened view of the vessel, a perpendicular CT slice, and a table of diameters by zone.
In plain terms, Coreline Soft said on Friday that the FDA cleared software that measures the aorta, zone by zone, on a chest CT a hospital already took. It is the company's 13th such clearance. It measures. It does not, on this filing, diagnose an aneurysm by itself.
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Sources
- Coreline Soft via PR Newswire — FDA 510(k) clearance for AVIEW Aorta Metrics, 23 Oct 2026
prnewswire.com
- FDA — 510(k) K260391, AVIEW Aorta Metrics
accessdata.fda.gov
- Coreline Soft — AVIEW Aorta Metrics product page
corelinesoft.com