Velacur

by Sonic Incytes Medical Corp.  · Based in Canada → — Health Insights You Can Count On
Gastroenterology Radiology

Contact for pricing
Regulatory Status Disclosed

Overview

Velacur by Sonic Incytes is an AI-guided, portable, point-of-care ultrasound elastography device designed for the non-invasive assessment and management of chronic liver diseases, such as Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD, formerly NAFLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH, formerly NASH). It is not an AI tool for a physician directory.

The device utilizes proprietary S-WAVE technology and an external activation source, similar to Magnetic Resonance Elastography (MRE), to generate shear waves throughout the liver. It provides 3D volumetric measurements of liver tissue stiffness (elasticity), attenuation (fat content), and Velacur Determined Fat Fraction (VDFF). Velacur boasts a measurement depth of up to 15 cm and a 3D tissue sample volume of up to 100 cm³, offering deeper and larger samples than traditional transient elastography.

Its artificial intelligence (AI) features include an Organ Guide, which overlays the B-Mode image to identify and color-code organs, making liver localization easier for operators, including those without extensive sonography experience. The Wave Quality Detector provides real-time feedback to optimize wave quality during a scan. These AI-powered tools enhance accuracy and enable confident measurements.

The procedure is quick, comfortable, and non-invasive, typically taking 5-10 minutes and can be performed by any trained medical professional after a one-day training session.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-guided real-time operation (Organ Guide, Wave Quality Detector)
  • 3D S-WAVE ultrasound elastography
  • Measures liver stiffness (elasticity), attenuation (fat), and VDFF
  • Non-invasive, point-of-care solution
  • Deeper measurements (up to 15 cm) and larger tissue samples (up to 100 cmu00b3)
  • External activation source similar to MRE
  • Portable and convenient design
  • Suitable for high-BMI patients
  • Single probe for various body types
  • Real-time results for immediate clinical assessment

Use Cases

  • Assessment of liver fibrosis and steatosis
  • Diagnosis and monitoring of MASLD/NAFLD
  • Diagnosis and monitoring of MASH/NASH
  • Management of chronic liver disease patients
  • Early detection of liver disease progression
  • Point-of-care liver health screening

What Physicians Need to Know

Real-Time AI Guidance
Velacur utilizes artificial intelligence to provide real-time guidance during liver ultrasound scans, facilitating liver visualization and optimizing wave quality. Its 'Organ Guide' AI tool identifies and color-codes the liver and surrounding anatomy on the B-mode image, simplifying liver localization for operators. Additionally, the 'Wave Quality Detector' monitors and confirms the presence of good-quality shear waves, offering real-time feedback to enhance measurement accuracy. These AI-powered features aim to improve device performance and enable medical personnel without extensive sonography experience to conduct accurate liver assessments.
Liver Pathology Analysis
Velacur is a non-invasive ultrasound imaging tool designed to measure liver stiffness (elasticity, indicating fibrosis) and attenuation (fat content, indicating steatosis). It provides quantitative measurements, including elasticity in kilopascals, attenuation in decibels per meter, and Velacur Determined-Fat Fraction (VDFF), which are crucial biomarkers for diagnosing and managing chronic liver diseases such as Metabolic dysfunction-associated Steatotic Liver Disease (MASLD) and Metabolic dysfunction-associated Steatohepatitis (MASH). The VDFF algorithm has demonstrated a strong correlation with MRI-PDFF, the gold standard for liver fat measurement, and high accuracy in detecting hepatic steatosis. The device offers deeper measurements (up to 15 cm) and larger 3D tissue samples (up to 100 cmu00b3) compared to transient elastography, making it suitable for a wider range of patients, including those with higher BMI.
Procedure Data & Tracking
The system generates accurate and reliable measurements of steatosis and fibrosis for immediate clinical assessment. It includes integrated patient data analytics, allowing healthcare providers to view and track a patient's liver health results over time, which supports ongoing monitoring and adjustments to care plans. The AI-guided workflow contributes to efficient procedures, with scans typically taking 5-10 minutes to perform.
Physician Tip

Velacur offers a non-invasive, point-of-care solution for the early detection and ongoing monitoring of chronic liver diseases like MASLD and MASH. Its AI-guided features simplify operation, making it accessible for various medical professionals to perform accurate liver stiffness and fat assessments. Physicians can leverage Velacur's quantitative measurements (elasticity, attenuation, VDFF) to track disease progression and evaluate treatment response, particularly changes in liver steatosis, which is a key predictor of therapeutic success. Integrating these objective measurements into routine patient management can enhance clinical decision-making and facilitate timely interventions.

Velacur is a portable, standalone point-of-care ultrasound device. While it does not integrate directly with endoscopy systems, its output of quantitative liver health data (stiffness and fat measurements) is crucial for comprehensive patient management. Seamless integration of this data into Electronic Medical Records (EMR) or Electronic Health Records (EHR) systems would be beneficial for longitudinal tracking, clinical workflow efficiency, and multidisciplinary care coordination.

Details

Category Gastroenterology AI, Radiology & Imaging AI
Pricing Contact for pricing
  • Low acquisition cost; capital investment or monthly payment options; typical reimbursement for CPT code 76981 is $106 (national, global rate); positive ROI within months
DeploymentOn-premise (portable device)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Velacur (K233977) received FDA 510(k) clearance on September 4, 2024, for its Velacur Determined Fat Fraction (VDFF) measurement. Earlier versions of Velacur also received FDA clearance, with AI-powered features cleared in May 2023, and the enhanced Velacur ONE receiving clearance in August 2025.

Integrations
EHR Not specified
Specialties Gastroenterology, Radiology

What the Web Says

Velacur is a non-invasive, point-of-care ultrasound device designed to assess liver health by measuring liver stiffness and fat (steatosis). It utilizes S-WAVE technology and 3D imaging, offering diagnostic accuracy comparable to MRI elastography and PDFF. Physicians and studies suggest it is a valuable tool for managing chronic liver diseases like fatty liver disease (MASLD/NAFLD) and steatohepatitis (MASH). It is considered a safe and easy-to-use method, even for children and young adults.

Overall: Positive

Strengths

  • Non-invasive and painless procedure.
  • High diagnostic accuracy comparable to MRI elastography and PDFF.
  • More effective than FibroScan at measuring liver fat (steatosis), especially in severe cases.
  • Equally effective as FibroScan at all fibrosis stages.
  • Quick procedure (around 5-10 minutes) with immediate results.
  • Portable and can be used in a physician's office, reducing the need for referrals to MRI centers.

Limitations

  • Some patients on medications that slow digestion (e.g., Ozempic) may need extended fasting for conclusive results.
  • In the lower range of stiffness tests, there might be a wider error range.
  • Limited information available from independent tech reviewers, G2, and Capterra.
  • Some users on Reddit have expressed confusion about comparing Velacur kPa scores to FibroScan legends, indicating a need for clearer comparative guidelines.
  • Patients with electronic implantable devices (e.g., pacemakers) are contraindicated.
  • Initial users may be inexperienced, though comprehensive training and remote assistance are provided.

Based on reviews from: Reddit, Landmark Digestive Health, Fatty Liver Foundation, GI Health, Capital Digestive Care, PMC (National Institutes of Health), Clinical Trials.gov, Sonic Incytes, Diagnostic Imaging, YouTube, Lippincott

Last updated: 2026-07-21

Ratings & Reviews

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Press & Coverage

Business Wire
FDA Grants 510(k) Clearance for Sonic Incytes' Velacur ONEu2122, AI-guided point of care ultrasound for the management of chronic liver diseases
Sonic Incytes Medical Corp announced that the FDA has granted 510(k) clearance for Velacur ONEu2122, an AI-guided point-of-care ultrasound elastography device for managing chronic liver diseases like MASH and MASLD. This next-generation device offers an enhanced interface, improved portability, and AI-based features for liver localization and higher reimbursement.
2025-08
Diagnostic Imaging
FDA Clears AI-Guided Point-of-Care Ultrasound for Liver Diseases
Velacur ONE, a point-of-care ultrasound device by Sonic Incytes, received 510(k) clearance from the FDA for assessing chronic liver diseases. Its proprietary Velacur-determined fat fraction (VDFF) algorithm shows a strong correlation with MRI-proton density fat fraction (PDFF), a key predictor for steatosis treatment effectiveness.
2025-08
Applied Radiology
Sonic Incytes Gains FDA Clearance for Velacur ONEu2122, Advancing Non-Invasive Liver Disease Diagnostics
Sonic Incytes Medical Corp announced FDA 510(k) clearance for Velacur ONEu2122, its next-generation point-of-care ultrasound elastography device, featuring an upgraded interface, improved portability, and enhanced user experience. The device measures attenuation, VDFF, and liver stiffness using 3D S-WAVE technology to aid in diagnosing and managing chronic liver conditions such as MASLD and MASH.
2025-08
Diagnostic Imaging Europe
FDA Clears AI-Guided Ultrasound Device for Liver Disease
The FDA has cleared Sonic Incytes' Velacur ONE, a portable point-of-care ultrasound elastography device with AI-guided functions for improved usability. It measures liver stiffness, attenuation, and VDFF, which are crucial for managing MASLD and MASH.
2025-09
PMC (Diagnostics)
Accuracy of Velacur in Assessing MASLD and MASH Patients Using Biopsy as the Gold Standard
This study validated Velacur's elasticity, attenuation, and VDFF measures against histological results, proving it a valid method to assess patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) and Metabolic Dysfunction-Associated Steatohepatitis (MASH). Velacur demonstrated high accuracy in diagnosing advanced liver fibrosis and steatosis.
2025-03
IT Medical Team
Revolutionizing Liver Diagnostics: Velacuru2122 as a Non-Invasive Tool for MASLD and MASH u2013 A Commentary on Recent Advances
This commentary reviews Velacur's accuracy in diagnosing MASLD and MASH, highlighting its potential as a non-invasive, ultrasound-based technology for assessing liver stiffness and fat content. It emphasizes Velacur's role in improving liver disease diagnostics in both research and clinical settings.
2025-05
Sonic Incytes
Sonic Incytes Announces FDA Clearance and US Launch of Velacur TM to Help Manage Emerging Health Crisis
Sonic Incytes Medical Corporation announced the US commercial release of Velacuru2122, the world's first handheld 3D liver health assessment tool with diagnostic accuracy comparable to MRI. This breakthrough solution aims to help healthcare practitioners better assess and manage fatty liver disease.
2020-10
Sonic Incytes
Sonic Incytes Announces Velacuru2122ufe0f use in Madrigal Pharmaceuticals' Open-Label Extension Clinical Trial
Sonic Incytes Medical Corp announced the inclusion of Velacuru2122 in a subset of Madrigal Pharmaceutical's MAESTRO NAFLD-1 Phase 3 Open Label Extension study. Patients will undergo Velacuru2122 imaging to evaluate liver stiffness and attenuation in this trial for a non-alcoholic steatohepatitis (NASH) treatment.
2022-06

Videos

Product demos, reviews, and walkthroughs for Velacur.

View all on YouTube

Frequently Asked Questions

Velacur is designed for point-of-care integration, similar to a standard ultrasound, making it suitable for a physician's office. Its AI guidance facilitates liver identification and optimizes wave quality in real-time, allowing operators with varying sonography experience to obtain confident measurements. This AI assistance aims to simplify the scanning process and reduce the need for extensive specialized training.
Velacur ONE, an enhanced version of the device featuring AI-guided functions, has received FDA 510(k) clearance for managing chronic liver diseases. While the search results confirm regulatory approval for the AI-guided device, specific details on patient data privacy and security protocols for its AI components are not explicitly detailed in the provided snippets.
Velacur utilizes S-WAVE technology and AI guidance to offer deeper tissue measurement and larger 3D tissue sampling compared to transient elastography like FibroScan. Studies have shown Velacur to outperform FibroScan in detecting steatosis and demonstrate equivalent efficacy in identifying advanced fibrosis, with its VDFF algorithm correlating strongly with MRI-PDFF, considered a gold standard for liver fat measurement.
Velacur is presented as a cost-effective diagnostic tool that often does not require pre-approval from insurance, making it more accessible. The Velacur ONE also integrates B-mode imaging, which can allow for higher reimbursement compared to non-imaging elastography. Specific pricing models are not detailed, but the emphasis is on affordability and ease of access.
While Velacur's AI guidance aims to improve usability and measurement confidence, the search results do not explicitly detail specific limitations of its AI-guided measurements or factors affecting accuracy in diverse patient populations. However, it is noted that Velacur's external activation source ensures shear wave penetration even in high BMI patients, addressing a common challenge in ultrasound-based assessments.
Velacur's AI primarily guides operators in real-time for liver identification and optimizing wave quality, making it easier to obtain accurate measurements. It assists in providing quantitative data on liver stiffness, attenuation, and fat fraction, which physicians then use along with other clinical indicators to aid in the clinical management and diagnosis of liver disease.
Sonic Incytes has received funding to enhance Velacur with an AI-based scanning guide to simplify accurate scans for non-expert users. While the current focus is on improving usability and measurement quality for liver assessment, the broader trend in healthcare AI suggests potential for expanded diagnostic applications and predictive analytics in future iterations, though specific plans beyond enhanced guidance are not detailed in the provided information.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21
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