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Liver Elastography Clinical Evidence

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Clinical Evidence

Peer-Reviewed.Independently Validated.Clinically Deployed.

Eieling’s clinical evidence spans 6 peer-reviewed journal publications, 2 international conference presentations, and a 1,593-patient prospective validation – covering liver fibrosis assessment, steatosis quantification, and AI-assisted point-of-care diagnostics. Every claim is anchored in published, citable research.

Liver International (IF 5.2)

APASL 2026

FDA 510(k) × 3

AUROC 0.97

FLAGSHIP PUBLICATION

Liver International · Q1 Gastroenterology & Hepatology

The Largest Independent Validation of a Point-of-Care Liver Elastography System

1,593

Patients

138 biopsy + 1,455 paired TE — largest prospective POC-TE validation.

0.97

AUROC

Cirrhosis (F4) detection — near-perfect classifier.

0.92

AUROC

Steatosis screening (≥S1) — excellent screening tool.

0.86

Pearson r

Fibrosis correlation vs. FibroScan® — high consistency with gold standard.

0.80

Pearson r

MAP vs. CAP® correlation (vs. FibroScan®) — strong agreement with established attenuation parameter.

4

Measurements

Non-inferior to standard 10 — exam time reduced from ~5-10 min to ~1 min.

4

AI models

ConvNeXt V2, Transformer-Hough, YOLOv8, BiSeNet V2 — purpose-built deep learning.

Citation: Huang Z-H, Ye C-H, Wu C-L, Li W-R, Deng M-Q, Lian L-Y, Huang C-X, Wei Y-X, Cao Y-Y, Shen X-N, Lin Y-W, Chen S-D, Seto W-K, Zheng Y-P, Zheng M-H. (2026). Identification of Hepatic Fibrosis and Steatosis via A Point-of-Care Transient Elastography System With Integrated AI. Liver International, 46(5), e70634. DOI: 10.1111/liv.70634

Wenzhou Medical University · Prof. Ming-Hua Zheng | University of Hong Kong / Queen Mary Hospital · Wai-Kay Seto

Published Research

Six Peer-Reviewed Publications. One Technology Platform.

#
Journal
Year
Core Finding
N

1

Liver International Q1 5.2

2026

AI-POC-TE validation: AUROC 0.97 (F4), r=0.86 vs FibroScan®

1,593

2

Insights into Imaging Q1 4.5

2024
Measurement site and respiration standardization
–

3

Diagnostics Q1 3.3
2024
r=0.975 vs conventional TE
121
4
BMC Gastroenterology Q2 2.6
2024
Body posture modulation study
–
5
Ultrasonics Q1 4.1
2024
Deep learning shear wave trajectory detection
–
6
Ultrasound Med Biol Q2 2.6
2013
Original validation: r=0.973
67
All publications available via DOI. Contact us for reprint requests.

Conferences

APASL 2026 — Istanbul, Turkey

Oral Presentation #2583. Presented by Prof. Jie Li’s team, Nanjing Drum Tower Hospital, Affiliated Hospital of Nanjing University Medical School.

Liverscan® vs. MRE & MRI-PDFF

Comparison
Spearman r
P Value

Liverscan® stiffness vs. MRE (all subjects)

0.62
< 0.001

Liverscan® MAP vs. MRI-PDFF (all subjects)

0.76
< 0.001

Liverscan® stiffness vs. MRE (MASLD subgroup)

0.57
0.0051

Liverscan® MAP vs. MRI-PDFF (MASLD subgroup)

0.45
0.037

Conclusion: Portable Liverscan® demonstrated good correlation with MRI-based gold standards — validating its role as a point-of-care screening and monitoring tool for MASLD.

FattaLab®

Built on Proven MAP Technology

Pilot Study (Completed)

Metric
Value
Design
Prospective, head-to-head, same-day comparison with Liverscan®
Sample
n = 68 MASLD patients
Pearson r vs. Liverscan MAP
0.87 (P < 0.001)
R²
0.76
Mean Absolute Error
4.2 dB/m

Post-Market Multicenter Studies (In Progress)

FattaLab® received FDA clearance (K253221, Feb 2026) and is currently in multicenter clinical trials in Hong Kong and Mainland China — including direct comparison with MRI-PDFF and FibroScan®. Results expected by year-end 2026.
Technical Foundation: FattaLab®’s MAP (Multi-domain Attenuation Parameter) technology originates from the same AI-driven attenuation analysis validated in the Liver International 2026 study — enhanced for dedicated fat quantification in a 120g wireless form factor.

Guidelines & Policy

Endorsed by Guidelines Accepted by Regulators

LSM in Clinical Guidelines

Source
Recommendation
FDA CDER (2025.08.27)
VCTE liver stiffness accepted as "reasonably likely surrogate endpoint" for MASH trials
AASLD 2024 (Rinella et al.)
LSM ≥8 kPa → significant fibrosis (≥F2); LSM ≥12 kPa → advanced fibrosis (≥F3)
Baveno VII Consensus (2022)
LSM <10 kPa rules out compensated advanced chronic liver disease
EASL 2023
Recommends TE for liver disease assessment in pregnancy

MASH Treatment Pipeline Driving Demand

Drug / Trial
Journal
Status
Tirzepatide (SYNERGY-NASH)
NEJM 2024
Phase II — MASH resolution significantly superior to placebo
Survodutide
NEJM 2024
Phase III ongoing
Pegozafermin + Semaglutide
JCI 2025
Large RCT for F2-F4 patients in progress
Every new MASH therapy requires liver fat monitoring. FattaLab is purpose-built for this workflow.

Collaborations

Evidence Built with Leading Research Centers

Institution
Region
Key Scholar
Collaboration
Wenzhou Medical University
Mainland China
Prof. Ming-Hua Zheng

Clinical trials, primary care screening

University of Hong Kong / QMH
Hong Kong
Wai-Kay Seto (Clarivate Top 1%)

Liver International 2026 co-author

HK Polytechnic University
Hong Kong
Prof. Yong-Ping Zheng (Stanford Top 2%)
Core technology inventor, R&D
Nanjing Drum Tower Hospital
Mainland China
Prof. Jie Li, Prof. Jun Chen
Liver International 2026 co-author
USTC Institute of Public Health
Mainland China
Prof. Wei Bao (Stanford Top 2%)
Lujiang Cohort collaboration

Timeline

2013-2026: A Decade of Peer-Reviewed Validation

2013

  • UMB n=67
  • r=0.973

2024

Trifecta

  • Diagnostics n=121, r=0.975
  • BMC Gastroenterology
  • Insights into Imaging
  • Ultrasonics
  • 3 Q1 papers

2026

Flagship

  • Liver Int’l n=1,593
  • AUROC 0.97
  • Q1 IF 5.2
  • APASL 2026 Oral

Soon

FattaLab®

  • Pilot r=0.87, n=68
  • Multicenter MRI-PDFF
  • Year-End 2026

Product Resources

Downloadable Evidence

Clinical Literature Compendium

Compare FattaLab® and Liverscan® by assessment need, workflow, clinical setting, and buyer use case.
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Liver International 2026 Reprint

Flagship paper reprint (subject to journal policy)
PDF >>