HepaFatSmart
Overview
HepaFatSmart is an advanced Software-as-a-Medical Device (SaMD) developed by Resonance Health. Leveraging artificial intelligence, it automatically analyzes magnetic resonance imaging (MRI) datasets to provide a quantitative assessment of a patient’s liver fat. The tool delivers three key liver fat biomarkers: volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and a steatosis grade. HepaFatSmart is designed to be non-invasive and painless, requiring only a short MRI scan. DICOM files are securely transmitted via Resonance Health’s FAST portal, and analysis is performed by its AI-powered engine, generating real-time results that are securely returned to the physician. This minimizes human error as no user input is required for the analysis. HepaFatSmart is an improved version that replaces HepaFat-AI, offering significantly enhanced diagnostic performance.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated AI-powered analysis of liver fat
- Multi-metric assessment: Volumetric Liver Fat Fraction (VLFF), Proton Density Fat Fraction (PDFF), Steatosis Grade
- Non-invasive, MRI-based solution
- Real-time results generation (within seconds of data upload)
- Secure DICOM file transfer via FAST portal
- Minimizes human error with no user input required for analysis
- Suitable for monitoring fatty liver diseases (NAFLD, NASH)
- Aids in assessment and screening of living donors for liver transplant
- Cloud-based user portal or onsite platforms
- Improved diagnostic performance over predecessor HepaFat-AI
Use Cases
- Quantitative assessment of liver fat in patients
- Monitoring fatty liver diseases, including NAFLD and NASH
- Aiding clinical decision-making for managing fatty liver-related diseases or metabolic syndromes
- Assessment and screening of living donors for liver transplant
- Supporting clinical diagnoses in individuals with confirmed or suspected fatty liver disease
- Use in pharmaceutical and therapeutic clinical trials
What Physicians Need to Know
HepaFatSmart offers a rapid, non-invasive, and highly accurate method for quantifying liver fat, crucial for managing conditions like NAFLD and NASH. Physicians should leverage its real-time, multi-metric reports for timely diagnostic support and monitoring treatment efficacy. Ensure MRI scans adhere to the specified protocols for optimal results, and always integrate the AI-generated data with comprehensive clinical judgment for patient management. Its utility in screening liver transplant donors is also a significant advantage.
HepaFatSmart is primarily accessed via Resonance Health's cloud-based FAST portal, ensuring secure data transfer. The flexibility to integrate with onsite platforms and third-party channel partners, such as CARPL.ai, facilitates seamless incorporation into existing Picture Archiving and Communication Systems (PACS) and clinical workflows, allowing for efficient analysis of MRI datasets.
Details
| Category | Endocrinology & Metabolic AI, Gastroenterology AI, Radiology & Imaging AI |
| Pricing | Contact for details — Contact for details |
| Deployment | Cloud-based (FAST portal) or onsite platforms |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated HepaFatSmart (V2.0.0) received US FDA 510(k) clearance (K231459) on June 20, 2023. It is classified as a Class II magnetic resonance diagnostic device for the quantitative assessment of liver fat. |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Gastroenterology, Radiology |
What the Web Says
HepaFatSmart is an FDA-cleared, AI-powered software as a medical device (SaMD) designed for the automated quantitative assessment of liver fat from MRI datasets. It calculates volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and provides a steatosis grade, aiding in the diagnosis and management of fatty liver disease and metabolic syndromes, as well as in assessing living donors for liver transplants. The software is an improvement over its predecessor, HepaFat-AI, and performs comparably to or slightly better than the manual analysis service, HepaFat-Scan.
Overall: PositiveStrengths
- Automated analysis reduces potential for human error.
- FDA-cleared as a Class II medical device.
- Provides multiple liver fat biomarkers (VLFF, PDFF, steatosis grade).
- Non-invasive, requires no additional equipment or contrast agents.
- Results are generated quickly (within seconds of data upload).
- High repeatability and reproducibility of results.
Limitations
- Effectiveness relies on the quality of input MRI images and adherence to specified imaging protocols.
- Automated software analysis still requires validation by trained healthcare professionals.
Based on reviews from: Medical News Observer, accessdata.fda.gov, Resonance Health, Listcorp, Trustpilot, G2
Last updated: 2026-07-22
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