Medical Device Network

FDA clears Coreline Soft’s AVIEW Aorta Metrics software

The regulatory clearance brings Coreline Soft’s total to 13 FDA 510(k) clearances and broadens its chest AI portfolio.

Coreline Soft has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its aortic quantitative analysis tool, AVIEW Aorta Metrics.

The regulatory clearance brings the company’s total to 13 FDA 510(k) clearances and broadens its chest computed tomography (CT) AI portfolio in the US.

The software automatically segments the aorta using chest CT scans and calculates quantitative diameter measurements throughout anatomical regions.

It classifies aortic zones and determines the diameter within each zone to assist clinicians with consistent quantitative evaluations.

The system also produces 3D views, cross-sectional imaging, and straightened curved planar reformation (CPR).

This regulatory addition is in line with Coreline Soft’s multi-disease analysis strategy for chest imaging in the American market, extending its analytical abilities outside pulmonary disease to encompass cardiovascular quantitative imaging.

To support multi-disease evaluation from a single chest CT examination, Coreline Soft offers products across its AVIEW platform, including AVIEW Aorta Metrics, AVIEW CAC, AVIEW LCS, and AVIEW Lung Nodule CAD.

Within this lineup, AVIEW CAC evaluates non-contrast chest CT scans to generate automated coronary artery calcium assessments and scoring.

For pulmonary analysis, AVIEW LCS and AVIEW Lung Nodule CAD identify lung nodules and deliver quantitative data for lung cancer screening programmes and nodule management.

The company's commercial activity in the US is expanding from individual hospital installations regarding deeper integration with healthcare platforms and clinical pathways.

Coreline Soft is collaborating with INFINITT North America to develop PACS-integrated, “zero-click” automation.

Separately, the company has collaborated with Oatmeal Health on lung cancer risk assessment strategies and US reimbursement pathways.

Coreline Soft is also partnering with Optellum to investigate incorporating AVIEW Lung Nodule CAD into wider lung nodule management, from initial detection and risk evaluation to follow-up care.