Coreline Soft has won FDA 510(k) clearance for AVIEW Aorta Metrics, software that automatically segments the aorta from a chest CT scan and measures its diameter zone by zone — no separate scan, no manual calipers. The Seoul, South Korea company's international announcement, dated 23 October 2026, puts the clearance's FDA decision date at 16 October 2026 and calls it the company's 13th U.S. 510(k) clearance, extending a chest-CT AI line that already reads the same scan for lung nodules, COPD and coronary artery calcium into cardiovascular measurement.
Thirteen clearances, in four figures
Figures from Coreline Soft's 23 October 2026 announcement and prior company disclosures.
What a thirteenth clearance buys a radiologist
A chest CT ordered to check for lung cancer or COPD already shows the aorta. Coreline Soft's pitch, repeated across its AVIEW line, is that the same scan should answer more than the question it was ordered for. AVIEW Aorta Metrics automates the part of a cardiovascular read that is otherwise done zone by zone with manual calipers: it segments the aorta, classifies it into standard anatomical zones, and measures diameter and volume for each one, producing a straightened curved-planar view, cross-sectional and 3D renderings, and a structured report, according to the product's own description on Coreline Soft's site.
FDA's 510(k) decision is dated 16 October 2026; Coreline Soft's international press release, distributed through PR Newswire Asia, followed on 23 October 2026. Korean trade coverage, including Korea Biomedical Review and Biotimes, reports the clearance as the company's 13th U.S. 510(k) and quotes CEO Kim Jin-kook saying the approval adds quantitative aortic analysis as a new use case built on the imaging workflows of Coreline Soft's existing American customers. This newsroom could not independently verify the clearance's K-number against FDA's own 510(k) database this run — a database aggregator lists one, but no press source states it, so this article treats the number as unconfirmed rather than print a figure Coreline Soft itself has not published.
“It is meaningful in that we can now add a new area of use, quantitative aortic analysis.” Kim Jin-kook, CEO, Coreline Soft — quoted by Korea Biomedical Review on the clearance, 2026
Three things that set AVIEW apart on a crowded shelf
One scan, one portfolio
Lung nodules, COPD, coronary artery calcium and now aortic measurement all read from a single chest CT under one AVIEW brand — a radiologist buys one workflow instead of stitching together separate point tools for each finding.
National-scale deployment already proven
Coreline Soft has been the sole quality-control provider to Korea's National Lung Cancer Screening Program for seven consecutive years, giving its lung-nodule AI a real-world volume most single-indication rivals have not reached.
Thirteen clearances, not one
A company's first FDA clearance is a bet; a thirteenth is a track record. Each new AVIEW module (COPD in one submission, coronary calcium in another, now the aorta) has cleared on its own 510(k), compounding a regulatory history a hospital's procurement office can check module by module.
A field already crowded with aorta AI
AVIEW Aorta Metrics does not open an empty category. RapidAI's Rapid Aortic holds its own FDA 510(k) for AI-enabled CT evaluation of the aorta, offering automated 3D reconstructions and what the company describes as 24 guideline-based measurements. Viz.ai's Viz Aorta takes a different approach, using deep learning to flag suspected aneurysms and dissections on CT angiography and move them up a radiology worklist rather than measure every zone. Incepto Medical's ARVA automates diameter measurement from the ascending aorta to the iliac arteries and compares results against a patient's prior scans; a 2025 validation study on 1,384 CT angiograms reported accuracy comparable to a clinician reader. Established imaging vendors, including Siemens' syngo.CT Vascular Analysis and TeraRecon's Intuition, offer semi-automated aortic modules of their own.
AVIEW Aorta Metrics against the aortic CT AI field
| Product | Vendor | What it measures | Output |
|---|---|---|---|
| AVIEW Aorta Metrics (Coreline Soft) | Automated zone segmentation, diameter & volume | Straightened CPR, cross-sectional & 3D views, quantitative report | FDA 510(k) cleared, Oct 2026 |
| Rapid Aortic (RapidAI) | Automated 3D reconstruction, guideline-based measurements | 3D reconstructions, measurement set | FDA 510(k) cleared |
| Viz Aorta (Viz.ai) | Suspected aneurysm & dissection detection | Worklist triage & prioritization | FDA cleared |
| ARVA (Incepto Medical) | Ascending aorta to iliac diameter, longitudinal comparison | Measurement report vs. prior scans | Validated in a 1,384-scan study |
From each company's own labelling, announcements and published validation studies; not a clinical comparison.
How big the AI-radiology shelf has to get
Aortic measurement is one line item in a much larger wager on AI reading medical images. Forecasts for that broader radiology-AI market vary by an order of magnitude depending on what a publisher counts, which is itself a tell about how early the category still is.
Radiology AI, sized two different ways
$0.76B → $2.27B
Global radiology AI market, 2025 to 2030, as forecast by MarketsandMarkets (2026), compared with The Business Research Company's considerably larger 2030 estimate for the same category.
Sources: MarketsandMarkets, Radiology AI Market Report 2025-2030 · The Business Research Company, AI in Radiology Market Report
Regulatory News outlook
We expect chest-CT AI vendors that already hold multiple cleared modules on one scan, Coreline Soft among them, to capture a disproportionate share of hospital radiology-AI budgets as buyers consolidate around fewer platforms rather than license a separate point tool per finding.
How we got here: MarketsandMarkets' $0.76B 2025 base compounded at its own stated 24.5% CAGR reaches roughly $2.3B by 2030, matching its published figure; we treat the wide gap to The Business Research Company's $10.7B estimate as evidence that most of this market's eventual size is still undefined by scope, not yet contradicted by either forecast.
From a Seoul radiology lab to thirteen clearances
Coreline Soft's road to AVIEW Aorta Metrics
- September 2012
Coreline Soft founded
Spun out of the radiology laboratory at Seoul National University College of Medicine to commercialize 3D medical imaging AI.
- 2023
KOSDAQ listing
Listed on South Korea's KOSDAQ exchange under its technology-specialty track, trading as KOSDAQ: 384470.
- 2024
AVIEW CAC cleared
FDA 510(k) clearance for AVIEW CAC, the company's AI coronary artery calcification assessment software.
- 2025
National screening program, year seven
Continued as the sole quality-control provider to Korea's National Lung Cancer Screening Program; signed a 10-year distribution deal with Canon Medical Systems covering lung-cancer screening deployments in Germany.
- 16 October 2026
AVIEW Aorta Metrics cleared
FDA 510(k) clearance for AVIEW Aorta Metrics, the company's 13th U.S. clearance, announced internationally on 23 October 2026.
- Ahead
U.S. teleradiology and PACS push
Coreline Soft says it plans to expand AVIEW adoption in U.S. medical institutions through teleradiology and PACS-integrated reading environments.
What the clearance does not cover
AVIEW Aorta Metrics measures; it does not diagnose dissection. Coreline Soft's separate AVIEW Aorta product, which Korean regulators have designated an innovative medical device, handles automated aortic dissection detection and is not part of this 510(k). The company has not published a labeled indication tying AVIEW Aorta Metrics to any specific patient population, screening interval or clinical decision threshold, and FDA's own 510(k) database entry for the clearance was not reachable from this newsroom's research environment this run to confirm the official K-number independently.
- Scope: automated aortic zone segmentation and diameter/volume measurement only; dissection detection is a separate, non-cleared product.
- K-number: not independently confirmed against FDA's own 510(k) database this run; this article does not print an unverified figure.
- U.S. go-to-market: teleradiology and PACS-integrated hospital workflows, built on Coreline Soft's existing American customer base.
- Portfolio context: the company's 14th consecutive year of operation and its 13th FDA clearance, following AVIEW LCS Plus, AVIEW COPD and AVIEW CAC.
Sources & further reading
- Coreline Soft, “Coreline Soft Receives U.S. FDA 510(k) Clearance for AVIEW Aorta Metrics, Expanding Its Chest CT AI Portfolio in the U.S.,” press release, 23 October 2026. en.prnasia.com
- “Coreline Soft gets FDA 510(k) for AVIEW Aorta Metrics,” Korea Biomedical Review, October 2026. koreabiomed.com
- “코어라인소프트, 대동맥 AI 분석솔루션 FDA 510(k) 허가…누적 13건,” Biotimes, October 2026. biotimes.co.kr
- “Coreline Soft Co., Ltd. Receives U.S. FDA Approval for Aortic Analysis AI… 13th Approval,” EDAILY, 19 October 2026. en.edaily.co.kr
- Coreline Soft, AVIEW Aorta Metrics product page. corelinesoft.com
- MarketsandMarkets, “Radiology AI Market worth $2.27 billion by 2030,” 2026. marketsandmarkets.com
Regulatory News reports on public regulatory documents. It is not legal advice, and the primary sources above govern. If we have made an error, we will say so in public: see corrections.
Frequently asked questions
What did FDA clear for Coreline Soft?
AVIEW Aorta Metrics, AI software that automatically segments the aorta on a chest CT, classifies it into anatomical zones, measures the diameter and volume of each zone, and generates a quantitative report alongside straightened, cross-sectional and 3D views. FDA's 510(k) decision was dated 16 October 2026; Coreline Soft announced it internationally on 23 October 2026.
Is this Coreline Soft's first FDA clearance?
No. It is the company's 13th U.S. 510(k) clearance, following earlier clearances for AVIEW LCS Plus (lung nodules and chest disease), AVIEW COPD and AVIEW CAC (coronary artery calcium).
Does the clearance cover aortic dissection detection?
No. AVIEW Aorta Metrics measures aortic diameter and volume by zone; it does not provide dissection detection, which is a feature of a separate Coreline Soft product, AVIEW Aorta, that is not part of this clearance.
Is Coreline Soft a public company?
Yes. It listed on South Korea's KOSDAQ exchange in 2023 under South Korea's technology-specialty listing track, trading as KOSDAQ: 384470.
