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LIVERSCAN®
TECHNOLOGY
CLINICAL VALIDATION
FDA · NMPA
Liverscan® Technical Whitepaper
From lab to life-saving screening. The definitive technical reference for Eieling's palm-sized wireless elastography system — covering B-mode imaging guidance, multidimensional sampling architecture, Liver International 2026 clinical validation (n=1,593, r=0.86 vs FibroScan®), and global regulatory certifications. Authored for clinicians, procurement decision-makers, and researchers.
r=0.86
VS FIBROSCAN® (FIBROSIS)
r=0.80
VS FIBROSCAN® (STEATOSIS)
AUROC 0.97
VS BIOPSY — CIRRHOSIS (F4)
AUROC 0.92
VS BIOPSY — STEATOSIS (S≥1)
~1 min
PER EXAM (4 MEAS.)
2× FDA
510(K) + NMPA + ISO
01
Introduction
In the past two decades, non-invasive liver assessment has undergone a revolutionary shift from tissue biopsy to quantitative imaging. Transient Elastography (TE) first emerged from French research labs in the late 1990s and entered clinical practice in 2003 with the commercialization of FibroScan®.
However, first-generation TE devices were limited by desktop design, reliance on A/M-Mode 1D ultrasound for positioning, and high operator dependency. Eieling Technology, building on Prof. Yong-Ping Zheng's pioneering soft tissue elastography laboratory research at Hong Kong Polytechnic University in B-mode real-time image-guided transient elastography, launched the world's first palm-sized wireless liver elastography device — Liverscan® — around 2020.It integrates B-mode 2D real-time ultrasound imaging with transient elastography into a single wireless composite probe.
Liverscan®'s core technology rests on two key patents: Prof. Zheng's B-mode imaging-guided TE (CN101843501 B / US8147410 B2), and Eieling's proprietary multidimensional tissue elasticity measurement method (CN111772677 A). These define the imaging guidance mechanism and the multi-point simultaneous sampling architecture, respectively.
As of May 2026, Liverscan has obtained 2 FDA 510(k) clearances, China NMPA Class III registration, and ISO 13485 QMS certification. Its clinical performance has been validated in Liver International and other peer-reviewed journals.
02
Transient Elastography: Technical Foundations & Comparison
Physical Principle
All quantitative elastography techniques exploit the relationship between shear wave propagation velocity in tissue and tissue stiffness. The fundamental physical relationship is: E = 3ρVs², where E is Young's modulus (kPa), ρ is tissue density (~1,000 kg/m³ for soft tissue), and Vs is shear wave velocity (m/s).
Elastography Technology Taxonomy
Technology
Imaging Modality
Shear Wave Source
Frequency (Liver)
Servo Control
Transient Elastography (TE)
Ultrasound
Transient mechanical vibration
~50 Hz
Optional
VCTE®
Ultrasound
Transient mechanical vibration
50 Hz
Yes
MRE
MRI
Harmonic mechanical vibration
50–60 Hz
No
ARFI/SWE
Ultrasound
Acoustic radiation force
Broadband
No
Liverscan® TE vs FibroScan®VCTE
Dimension
Liverscan® TE
FibroScan® VCTE
Shear wave frequency
~50 Hz
50 Hz (liver) / 100 Hz (spleen)
Imaging guidance
B-mode 2D real-time ultrasound
M-Mode / A-Mode 1D ultrasound
Probe design
Wireless palm-sized composite probe
Wired desktop probe
Required measurements
4 (vs FibroScan® 10)
10 valid measurements
Exam time
~1 minute
~5 –10 minutes
Device weight
Palm-portable (<500g probe)
Desktop (>10kg)
FDA product code
IYO (substantially equivalent to FibroScan)
IYO
Cost positioning
~50% lower than FibroScan®
Baseline
03
Liverscan® System Architecture
Three Integrated Subsystems
Subsystem
Function
Technical Highlights
B-mode ultrasound transducer
Real-time 2D imaging
Visualizes liver parenchyma, avoids ribs/vessels/nodules
TE vibration actuator
Shear wave generation
Electrodynamic drive, low-frequency mechanical pulse at skin surface
Ultrasound tracking unit
Shear wave propagation monitoring
High-frame-rate pulse-echo ultrasound for tissue displacement tracking
The probe transmits data via wireless connection (Wi-Fi) to a companion display terminal (laptop, tablet, or all-in-one). No traditional desktop host required.
Control Mechanisms
- B-mode real-time guidance: Operator visualizes liver parenchyma in 2D, precisely avoiding ribs, vessels, and artifacts.
- Force feedback: Built-in force sensor monitors contact pressure, ensuring optimal applied force.
- Multi-point sampling: Parallel sampling architecture (CN111772677 A) improves spatial coverage and measurement representativeness.
04
Core Technical Innovations
4.1 B-Mode Real-Time Imaging Guidance
Traditional TE devices use M-Mode or A-Mode 1D ultrasound for positioning — the operator sees only echo intensity changes along a single scan line. This is particularly challenging in obese patients, narrow intercostal spaces, or atrophic livers.
Liverscan®'s B-mode 2D real-time ultrasound imaging provides a real cross-sectional image of liver parenchyma, enabling operators to directly see liver boundaries, rib and vessel positions, and cystic/nodular structures to avoid.
Patent foundation: CN101843501 B — B-mode imaging-guided transient elastography (PolyU, Prof. Yong-Ping Zheng).
4.2 Multidimensional Multi-Point Sampling (CN111772677 A)
Eieling's proprietary patent defines a tissue elasticity measurement method with
dimensionality. Key innovations include multi-point simultaneous sampling,
elasticity map spatial registration with B-mode images, and efficiency gains — reducing
required measurements from 10 to 4 and exam time to ~1 minute.
05
Examination Workflow & Output Parameters
5-Step Examination
1
Patient preparation
Supine, right arm behind head, expose right intercostal space. Fasting ≥ 3 hours recommended.
2
Probe positioning
Under B-mode real-time imaging guidance, place probe at right intercostal space and observe liver parenchyma.
3
Trigger measurement
Once B-mode confirms probe alignment with suitable liver parenchyma, trigger measurement.
4
Automatic acquisition
System performs 4 valid measurements automatically.
5
Results output
Reports final LSM and MAP values as median ± IQR/M ratio.
Output Parameters
Parameter
Abbreviation
Measures
Unit
Clinical Significance
Liver Stiffness Measurement
LSM
Shear wave velocity → Young's modulus
kPa
Fibrosis staging (F0–F4)
Mobile Attenuation Parameter
MAP
Ultrasound attenuation coefficient in liver tissue
dB/m
Steatosis quantification (S0–S3)
vs Traditional Methods
Method
Invasive
Time
Repeatability
Use Setting
Liver biopsy
Invasive
Days
Low (sampling variability)
Gold standard, limited
Conventional TE
Non-invasive
~10 min
Medium
Hospital / specialist clinic
Liverscan®
Non-invasive
~1 min
High
Hospital + Primary Care + Pharmacy
MRI-PDFF
Non-invasive
~30 min
High
Tertiary hospital / research center
06
Clinical Validation
Flagship Study: Liver International 2026
In collaboration with Prof. Wai-Kay Seto's team at Queen Mary Hospital, University of Hong Kong, published in Liver International (2026): Identification of Hepatic Fibrosis and Steatosis via A Point-of-Care Transient Elastography System With Integrated AI.
Metric
Result
FibroScan® Correlation
Liver fibrosis (LSM)
r = 0.86
High agreement
Steatosis (MAP)
r = 0.80
Good agreement
Overall accuracy
90%
—
Exam time
~1 minute
FibroScan® 5–10 minutes
FDA Substantial Equivalence
Both FDA 510(k) clearances (K233401 and K242496) were based on Substantial Equivalence to FibroScan®. Product code IYO, regulation 21 CFR 892.1560 — Class II.
FDA Regulatory Milestone (2025-08-27)
FDA CDER formally accepted VCTE-measured Liver Stiffness Measurement (LSM) as a "reasonably likely surrogate endpoint" for MASH all-cause mortality. As a same technology-platform TE device, Liverscan directly benefits from this regulatory validation.
07
Regulatory Certifications & Global Market Access
Market
Certification
Number
Date
USA
FDA 510(k)
K233401
2024
USA
FDA 510(k)
K242496
2024
Mainland China
NMPA Class III
国械注准20243071846
2024
Hong Kong
MDD
251716
2025
Indonesia
MOH
812000474256900020032
2025
Malaysia
MDA
GB2187626-231111
2026
Thailand
Thai FDA
69-2-2-2-0001912
2026
Vietnam
MOH
250000351/PCBB-HCM
2025
08
Clinical Applications
Applicable Departments
Infectious Disease · Gastroenterology · Hepatobiliary Surgery · Endocrinology · Cardiology · Operating Room · Emergency · Bariatric Clinic · Health Checkup Center · Community Pharmacy
Clinical Indications
• Chronic hepatitis B/C fibrosis assessment
• MAFLD/MASLD steatosis & fibrosis staging
• MASH progression monitoring
• Alcoholic liver disease assessment
• Primary sclerosing cholangitis
• Wilson disease monitoring
• Cirrhosis differentiation & portal hypertension risk assessment
• GLP-1 receptor agonist pre/post-treatment liver monitoring
GLP-1 Companion Diagnostic Positioning
In August 2025, FDA approved Wegovy® for MASH treatment — the first GLP-1 drug approved for liver disease. Liverscan and its sister product FattaLab are positioned as full-journey companion monitoring tools for GLP-1 therapy:
Pre-treatment Baseline → On-treatment Monitoring → Post-treatment Long-term Management
09
Conclusion & References
Liverscan® represents a paradigm shift in transient elastography — from desktop devices to palm-sized wireless, AI-driven, multi-scenario deployment. B-mode real-time imaging guidance addresses the core pain point of traditional TE devices. The multi-point sampling architecture more than doubles examination efficiency.
From Prof. Zheng's original laboratory research at PolyU, to 2 FDA 510(k)s, NMPA Class III certification, and Liver International peer-reviewed publication — Liverscan's technology pathway validates the complete cycle from basic research through clinical translation to global regulatory recognition.
Key References: Sandrin L et al. Ultrasound Med Biol, 2003 · Zheng YP, US8147410 B2 · Huang Z-H et al. CN111772677 A · Seto W-K et al. Liver International, 2026 · FDA K233401 / K242496