Guide to Non-Invasive Liver Diagnostic Devices: Technology and Leading Organizations Explained
Non-invasive liver diagnostic devices are changing the detection and management of liver disease. Leading device-based solutions demonstrate this innovative technology and provide numerous clinical benefits. Here's a guide to how they work and what to consider.
How do non-invasive liver diagnostic devices work?
These types of devices typically utilize quantitative imaging-based elastography to assess liver stiffness as a marker of fibrosis and in some cases provide a measurement of steatosis (i.e., the accumulation of fat in the liver). The main technique is transient elastography (TE), which generates mechanical pulse vibration waves in the liver and uses ultrasound to assess the velocity related to tissue stiffness.
Another technique is shear wave absolute vibration elastography (S-WAVE). It uses external paddles to generate multi-frequency steady-state waves, which are then imaged in 2D and 3D ultrasound. Individual systems may add proprietary enhancements to these underlying technologies, but they are still fundamentally device-based rather than lab- or ultrasound-cart-based software add-ons.
3 Leading Liver Diagnostic Equipment Organizations
When it comes to standalone diagnostic equipment, there are three main options, each with its own unique advantages.
1.Echosens——FibroScan®
Echosens launches FibroScan® 2003 – It is the first commercially available transient elastography device designed to assess liver fibrosis and steatosis. FibroScan uses painless vibrations generated on the surface of the skin and uses ultrasound to track wave speeds within the liver. These measurements output reliable liver stiffness measurements as well as CAP™ for quantifying liver fat and SSM for portal hypertension assessment.
FibroScan is clinically validated in more than 5,000 peer-reviewed publications and recommended in more than 200 international guidelines. The devices are portable or cart-mounted and are used worldwide in primary care, hepatology, endocrinology and research.
The exam takes less than 10 minutes, requires no blood draws or fasting, and generates quantitative, reproducible reports. FibroScan's unparalleled clinical validation and extensive global footprint make it the standard reference for liver elastography.
Main features
- Real-time liver stiffness and steatosis quantification
- Fast, non-invasive testing
- Portable and suitable for clinical use, with options to suit all clinic sizes
- User-friendly interface and automated reporting
- Extensive integration with hospital EMR systems
- Backed by a global clinically validated database
2. Haisky Medical——iLivTouch®
Hisky Medical – founded in 2010 and headquartered in China – launches iLivTouch® Series provides next generation device-based transient elastography for the treatment of liver disease. The device uses innovative dynamic broadband scanning that combines TE for stiffness and ultrasound attenuation for fat quantification.
It delivers smart diagnostics, ergonomics for point-of-care, and robust, reproducible results with patented algorithms for high precision. The FT100 is lightweight and portable for use in the field or in the clinic, while the FT1000 is a cart-based system best suited for hospitals. Both models are touch screen operated.
Clinical evidence supports multiple validations, and it has obtained national and global patent authorization. Training and after-sales support are the company's top priorities.
Main features
- Simultaneous quantitative measurement of fibrosis and steatosis
- Dynamic broadband probe improves detection of darker or obese patients
- Lightweight FT100 has up to 3 hours of battery life for mobile screening
- Automated reporting and workflow integration
- Multiple innovative patents
- Provide comprehensive product/technical training
3. SonicIncytes — Velacur™
Founded in 2017, SonicIncytes launched Velacur™ to provide fast, precise, device-based liver quantification. This device uses S-WAVE technology instead of traditional TE to enable millimeter-resolution stiffness maps and volumetric fat analysis in 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 artificial intelligence guidance to assist operators with no ultrasound experience. Organ guides color-code organs to assist with liver location, and a wave quality detector ensures good waves are present.
The clinical validator showed high concordance with liver biopsies, and the device is particularly known for its multi-site, multi-depth sampling. Cloud-based software enables automated results storage and sharing.
Main features
- Proprietary wave imaging for multi-site, high-resolution quantification
- Provides analysis of liver stiffness and steatosis
- Compact, portable, battery powered
- Designed for non-experts to operate in any clinic setting
- AI-assisted operation
- Cloud-enabled data storage and integrated reporting
Compare Non-Invasive Liver Diagnostic Devices
Featured tissues and devices are selected based on clinical validation, innovative technology and proven performance. Evaluate them based on your clinical needs.
| Echosens Fiber Scanner | Haisky Medical iLivTouch | Sonic Incets Verakul | |
| Main technology | Transient elastography (TE) | Dynamic Broadband TE | transverse wave |
| portability | Portable and cart models | Portable and cart models | Highly portable, battery-based |
| clinical evidence | extensive and global | National/Global Patents and Validations | US/Canada multi-site trial and strong biopsy consistency |
| Operation | Specialist and primary care | Specialty, Primary Care, Outreach | Designed for use by any clinical staff |
| Integration | EHR/EMR connectivity | Automated simplified reporting | Cloud-based data sharing |
How should a clinic choose equipment?
Healthcare organizations seeking non-invasive liver diagnostic devices should weigh a number of factors before making a decision. These include:
- Clinical evidence and guidance: FibroScan is certainly the leader in global validation and guidance, but the other two devices also have strong support.
- Portability and workflow needs: For remote or on-site screening, Velacur excels in compactness and usability, making it accessible to a wide range of clinicians.
- Desired depth and resolution: If precise volumetric liver mapping is required or difficult patients are the focus, Velacur's 3D imaging or iLivTouch's broadband technology are advantageous.
- Cost and regional availability: iLivTouch may provide a more cost-effective solution in Asia and emerging markets.
Selection should be based on patient population metrics, such as obesity or hepatitis prevalence, as well as clinical workflow, required guideline compliance, physical space constraints, and budget.
Technology leads the way to liver diagnosis
Leading non-invasive liver diagnostic device at the forefront of the fight against liver disease. By providing extensive clinical validation and including
