Non-invasive liver diagnostic devices are transforming the detection and treatment of liver disease. Leading device-based solutions showcase this innovative technology and offer numerous clinical benefits. Here’s a guide on how they work and what to consider.
How do non-invasive liver diagnostic devices work?
These types of devices typically use quantitative image-based elastography to assess liver stiffness as a marker of fibrosis and, in some cases, provide measures for steatosis, which is the accumulation of fat in the liver. The primary technology is transient elastography (TE), which generates mechanical pulse vibration waves in the liver and uses ultrasound to assess velocity, which correlates with tissue stiffness.
An alternative technology is shear wave absolute vibroelastography (S-WAVE). It uses an external paddle to generate steady-state multifrequency waves, which are then imaged in 2D and 3D ultrasound. Individual systems may add proprietary enhancements to these core technologies, but they remain fundamentally device-based rather than lab-based or software add-ons to ultrasound carts.
3 leading organizations in liver diagnostic devices
For standalone diagnostic devices, there are three main options, each with their own advantages.
1. Echosens – FibroScan®
Echosens introduced FibroScan® in 2003, it was the first commercially available transient elastography device designed for the evaluation of hepatic fibrosis and steatosis. FibroScan uses painless vibrations generated on the surface of the skin, with ultrasound tracking the speed of the wave within the liver. These measurements generate reliable values for measuring liver stiffness, as well as CAP™ for quantifying liver fat and SSM for the assessment of portal hypertension.
FibroScan is clinically validated in over 5,000 peer-reviewed publications and recommended in over 200 international guidelines. The units are portable or cart-mounted and are used worldwide in primary care, hepatology, endocrinology and research.
The exams last less than 10 minutes, do not require blood tests or fasting, and provide quantitative and reproducible reports. FibroScan’s unparalleled clinical validation and broad global footprint make it the reference standard for liver elastography.
Key Features
- Quantification of liver stiffness and steatosis in real time.
- Quick and non-invasive exams
- Portable and clinic-friendly with options for offices of all sizes
- Easy-to-use interface and automated reporting
- Extensive integration with hospital EMR systems
- Backed by a global clinical validation database
2. Hisky Medical – iLivTouch®
Hisky Medical, founded in 2010 and based in China, launched iLivTouch® series to offer next-generation device-based transient elastography for liver diseases. Using innovative broadband dynamic scanning, the device combines TE for stiffness and ultrasound attenuation for fat quantification.
It offers intelligent diagnosis, ergonomic point-of-care design, and robust, repeatable results with proprietary algorithms for high precision. The FT100 is lightweight and portable, for clinical or field use, while the FT1000 is a cart-based system more suitable for hospitals. Both models use touch screen operation.
Clinical evidence supports multiple validations, with patents granted nationally and globally. Training and after-sales support are key company priorities.
Key Features
- Simultaneous quantitative measurement of fibrosis and steatosis.
- Dynamic broadband probe improves detection in deeper or obese patients
- The lightweight FT100 offers 3 hours of battery life for mobile detection
- Automated reporting and workflow integration
- Multiple innovative patents
- Comprehensive technical/product training provided
3. SonicIncytes—Velacur™
SonicIncytes was established in 2017 and introduced Velacur™ to offer rapid and accurate device-based liver quantification. This device uses S-WAVE technology instead of classic TE to provide millimeter-resolution stiffness maps and volumetric fat analysis from a compact, portable device. In particular, 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 ultrasound experience. An organ guide color codes the organs to aid in liver location and a wave quality detector ensures good waves are present.
Clinical validators show high concordance with liver biopsy and the device is especially notable for its sampling at multiple sites and depths. Cloud-based software allows for automated storage and sharing of results.
Key Features
- Proprietary wavelet imaging for high-resolution quantification at multiple sites
- Provides analysis of liver stiffness and steatosis.
- Compact, portable and battery operated
- Designed to be used by non-specialists in any clinical setting.
- AI assisted operation
- Cloud-enabled data storage and integrated reporting
Comparison of non-invasive liver diagnostic devices
Featured organizations and devices were selected based on clinical validation, innovative technologies, and proven performance. Evaluate them based on your clinical needs.
| FibroScan Echosens | Hisky Medical iLivTouch | SonicIncytes Velacur | |
| Main technology | Transient elastography (TE) | Dynamic Wideband TE | S WAVE |
| Portability | Portable and cart models. | Portable and cart models. | Highly portable, battery-based |
| Clinical evidence | Broad and global | Patents and national/global validations. | Multicenter trials in the US and Canada and strong concordance in biopsies |
| Operation | Specialized and primary care | Specialist, primary care, extension. | Designed to be used by any clinical staff. |
| Integration | EHR/EMR Connectivity | Automated and optimized reports | Cloud-based data sharing |
How clinics should choose between devices
Healthcare facilities seeking non-invasive liver diagnostic devices must 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 the other two devices also have strong support.
- Portability and Workflow Needs: For remote or field sensing, Velacur stands out for its compact size and ease of use for a wide range of clinicians.
- Required depth and resolution: If accurate, volumetric liver maps are required or if the focus is on difficult patients, Velacur’s 3D imaging or iLivTouch’s broadband technology are advantageous.
- Regional Cost and Availability: iLivTouch can offer a more affordable 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, compliance with required guidelines, physical space limitations, and budget.
Technology leads the way in liver diagnosis
Leading non-invasive liver diagnostic devices are at the forefront of the battle against liver diseases. Offering extensive clinical validation and inc.