Noninvasive liver diagnostic devices are transforming the detection and management of liver disease. The leading device-based solutions showcase this innovative technology and offer numerous clinical benefits. Here’s a guide to how they work and what to consider.
How Do Noninvasive Liver Diagnostic Devices Work?
These types of devices typically utilize quantitative imaging-based elastography to assess liver stiffness as a marker for fibrosis and provide measures for steatosis in some cases, which is the accumulation of fat in the liver. The principal technology is transient elastography (TE), which generates mechanical pulse vibration waves in the liver and uses ultrasound to assess the velocity, which correlates with tissue stiffness.
An alternative technology is shear wave absolute vibro-elastography (S-WAVE). This uses an external paddle to generate multifrequency steady-state waves, which are then imaged in 2D and 3D ultrasound. Individual systems may add proprietary enhancements to these base technologies, but they remain fundamentally device-based rather than being lab-based or software add-ons to ultrasound carts.
3 Leading Liver Diagnostic Device Organizations
For stand-alone diagnostic devices, there are three primary options, each with its own distinct strengths.
1. Echosens — FibroScan®
Echosens introduced FibroScan® in 2003 — it was the first commercially available transient elastography device designed for the assessment of liver fibrosis and steatosis. FibroScan uses painless vibrations generated at the skin surface, with ultrasound tracking wave velocity within the liver. These measurements output reliable liver stiffness measurement values as well as CAP™ for quantifying liver fat and SSM for portal hypertension assessment.
FibroScan is clinically validated in over 5,000 peer-reviewed publications and recommended in more than 200 international guidelines. Units are portable or cart-based and used worldwide in primary care, hepatology, endocrinology and research.
Exams take under 10 minutes, with no bloodwork or fasting required, and yield quantitative, reproducible reports. FibroScan’s unparalleled clinical validation and broad global footprint make it the standard reference for liver elastography.
Key Features
- Real-time liver stiffness and steatosis quantification
- Rapid, noninvasive exams
- Portable and clinic-friendly with options for all practice sizes
- User-friendly interface and automated reporting
- Extensive integration with hospital EMR systems
- Supported by a global clinical validation database
2. Hisky Medical — iLivTouch®
Hisky Medical — founded in 2010 and headquartered in China — launched the iLivTouch® series to deliver next-generation device-based transient elastography for liver disease. Using innovative dynamic wideband scanning, the device combines TE for stiffness and ultrasound attenuation for fat quantification.
It offers intelligent diagnosis, ergonomic design for point-of-care and robust repeatable results with patented algorithms for high accuracy. The FT100 is lightweight and portable, for field or clinic use, while the FT1000 is a cart-based system best suited for hospitals. Both models use touch screen operation.
Clinical evidence supports multiple validations, with national and global patents granted. Training and after-sales support are key company priorities.
Key Features
- Simultaneous quantitative measurement of fibrosis and steatosis
- Dynamic wideband probe improves detection in deeper or obese patients
- Lightweight FT100 offers 3 hours of battery life for mobile screening
- Automated reporting and workflow integration
- Multiple innovative patents
- Comprehensive product/technical training provided
3. SonicIncytes — Velacur™
SonicIncytes was established in 2017 and introduced Velacur™ to deliver rapid, precise, device-based liver quantification. This device employs S-WAVE technology instead of classical TE to facilitate millimeter-resolution stiffness maps and volumetric fat analysis from a compact, portable device. Notably, Velacur is designed for easy operation in primary care, endocrinology and remote clinics, requiring minimal space and training.
The device uses AI guidance to assist operators without sonography experience. An Organ Guide color-codes organs to assist in liver location, and a Wave Quality Detector ensures that good waves are present.
Clinical validators show high concordance with liver biopsy, and the device is especially noted for its multisite, multidepth sampling. Cloud-based software enables automated result storage and sharing.
Key Features
- Proprietary wave imaging for multisite, high-resolution quantification
- Delivers both liver stiffness and steatosis analysis
- Compact, portable and battery-operated
- Designed for operation by non-specialists in any clinic setting
- AI-assisted operation
- Cloud-enabled data storage and integrated reporting
Comparing Noninvasive Liver Diagnostic Devices
The featured organizations and devices were selected based on clinical validation, innovative technologies and proven performance. Evaluate them according to your clinical needs.
| Echosens FibroScan | Hisky Medical iLivTouch | SonicIncytes Velacur | |
| Main Tech | Transient Elastography (TE) | Dynamic Wideband TE | S-WAVE |
| Portability | Portable and cart models | Portable and cart models | Highly portable, battery-based |
| Clinical Evidence | Extensive and global | National/global patents and validations | Multisite U.S./Canada trials and strong biopsy concordance |
| Operation | Specialist and primary care | Specialist, primary care, outreach | Designed for use by any clinical staff |
| Integration | EHR/EMR connectivity | Automated streamlined reporting | Cloud-based data sharing |
How Clinics Should Choose Between Devices
Health care facilities seeking noninvasive liver diagnostic devices should weigh a number of factors before making a decision. These include:
- Clinical evidence and guidelines: FibroScan is the clear leader in global validation and guidelines, but both other devices are also strongly supported.
- Portability and workflow needs: For remote or field screening, Velacur excels in compactness and usability by a broad range of clinicians.
- Depth and resolution needed: If precise, volumetric liver maps are required or difficult patients are a focus, Velacur’s 3D imaging or iLivTouch’s wideband technology are advantageous.
- Cost and regional availability: iLivTouch may offer a more cost-accessible solution in Asia and emerging markets.
Selection should be based on patient population metrics such as obesity rates or hepatitis prevalence, as well as clinical workflow, required guideline adherence, physical space constraints and budget.
Technology Leads the Way in Liver Diagnostics
The leading noninvasive liver diagnostic devices are at the forefront of the battle against liver disease. By offering extensive clinical validation and inc