HepaFat-AI
Overview
HepaFat-AI, developed by Resonance Health, is an AI-driven, non-invasive software-as-a-medical-device (SaMD) designed for the automated, real-time multi-metric assessment of liver fat in patients. It automatically analyzes magnetic resonance imaging (MRI) datasets to provide clinicians with a comprehensive solution for use in the assessment of individuals with confirmed or suspected fatty liver disease. The tool generates detailed patient reports, including NASH-CRN Steatosis Grading, Proton Density Fat Fraction (PDFF), and a liver fat distribution map. HepaFat-AI was validated for use with all major MRI scanner makes and models and could be accessed via Resonance Health’s cloud-based portal or through channel partners. It was also utilized in drug trials for real-time data collection, particularly for Non-Alcoholic Steatohepatitis (NASH). Please note that HepaFat-AI has been succeeded by HepaFatSmart, an updated AI-trained liver-fat assessment software, which offers improved diagnostic performance and is replacing HepaFat-AI in all markets.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Automated analysis of MRI datasets for liver fat assessment
- Provides comprehensive multi-metric solution for fatty liver disease
- Reports NASH-CRN Steatosis Grading
- Provides Proton Density Fat Fraction (PDFF)
- Generates a patient report with a liver fat distribution map
- Non-invasive
- Validated for all major MRI scanner makes and models
- Can be used in drug trials for real-time data
Use Cases
- Assessment of individuals with confirmed or suspected fatty liver disease
- Monitoring of patients prescribed medications known to induce steatosis
- Late effects monitoring of cancer patients for fatty liver changes
- Guidance with treatment planning for liver disease or liver cancer
- Screening for suitability of living donors for liver transplants
- Assisting in drug trials, particularly for NASH
What Physicians Need to Know
HepaFatSmart offers a non-invasive, quantitative assessment of liver fat, providing critical metrics (VLFF, PDFF, steatosis grade) that can aid in the early diagnosis, monitoring, and management of fatty liver diseases like NAFLD/MASLD. Its automated nature reduces variability and potential for human error, offering a standardized approach for clinical decision-making and patient counseling. Consider its utility for screening at-risk populations, monitoring treatment efficacy, and in the assessment of potential liver donors. Always ensure MRI images adhere to the specified protocols for optimal accuracy.
The primary integration method involves uploading DICOM images to Resonance Health's FAST cloud-based portal. This cloud-native approach simplifies deployment and access, eliminating the need for complex on-premise installations. Future integrations may include direct partnerships with radiology channel partners to further streamline workflow within existing imaging ecosystems.
Details
| Category | Endocrinology & Metabolic AI, Gastroenterology AI, Radiology & Imaging AI |
| Pricing | Unknown |
| Deployment | Cloud-based portal; via radiology-based channel partners |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated HepaFat-AI received US FDA clearance in December 2020 under the 510(k) premarket notification process (K201039), classified as a Class II magnetic resonance diagnostic device. It has since been replaced by HepaFatSmart, an updated AI-trained liver-fat assessment software, which received US FDA clearance in June 2023 and offers improved diagnostic performance. |
| Integrations | |
| EHR | Not specified |
| Specialties | Endocrinology, Gastroenterology, Radiology |
Ratings & Reviews
No reviews yet. Be the first to review this tool!
Rate HepaFat-AI
Press & Coverage
Videos
Product demos, reviews, and walkthroughs for HepaFat-AI.
Rick Astley - Never Gonna Give You Up (Official Video) (4K Remaster)
