Can an app interpret a Magnetic Resonance Imaging (MRI) scan?

Can Apps Interpret MRI Scans? Current Capabilities and Limitations

While some apps with FDA clearance and CE marks can assist with specific MRI analysis tasks, no app can fully replace radiologist interpretation of MRI scans due to limitations in validation, potential software errors, and the complexity of clinical decision-making. 1, 2

Current State of MRI Analysis Software

Approved Software Applications

Several software packages have received regulatory approval for specific MRI analysis tasks:

• IcoBrain MS (previously MSmetrix): Provides cross-sectional volumes and longitudinal changes in gray/white matter. Has both CE mark and FDA clearance. 1
• NeuroQuant: Offers cross-sectional and longitudinal quantification of brain atrophy. Available as remote service or local installation with CE mark and FDA clearance. 1
• Biometrica MS: Built on Statistical Parametric Mapping for atrophy measurement with CE mark but not FDA clearance. 1
• Quantib Brain: Integrated with GE MRI scanners for brain volume analysis with CE mark and FDA clearance. 1

Validation Status

Despite regulatory approvals, most of these applications have significant limitations:

• Only MSmetrix (IcoBrain MS) has been independently validated specifically for multiple sclerosis by groups outside the developing company. 1
• The real-world clinical value of these software packages has not yet been thoroughly assessed. 1
• These applications are not widely reimbursed, with few exceptions such as in the USA. 1

Key Limitations of MRI Analysis Apps

Technical Challenges

• Software Errors: As software complexity increases, the likelihood of undiscovered bugs approaches certainty. A 15-year-old bug was recently discovered in widely used neuroimaging software (AFNI program 3dClustSim), affecting numerous published studies. 1
• Validation Issues: Most applications have not been extensively validated on independent datasets, particularly for specific clinical conditions. 1
• Spinal Cord Analysis: Assessment of spinal cord atrophy is particularly challenging due to anatomical features (higher mobility, smaller dimensions) and imaging characteristics (lower tissue contrast). 1

Clinical Implementation Barriers

• Interpretation Complexity: MRI findings must be interpreted with knowledge of clinical and laboratory information to avoid misdiagnosis. 1
• Expertise Requirements: Scans should be interpreted by experienced readers capable of fully assessing evidence for and against specific diagnoses. 1
• Contextual Understanding: AI/ML analytics must be presented through intuitive interfaces that enhance user trust and integrate with existing clinical workflows. 1

Artificial Intelligence in MRI Interpretation

The American Heart Association states that AI/ML should augment and support clinical decision-making rather than replace clinical judgment needed for evidence-based practice. 1 Key considerations include:

• Interpretability: Understanding complex algorithms remains challenging, though complete understanding may not always be essential if efficacy is demonstrated. 1
• Performance Degradation: Algorithm performance may degrade over time due to changes in patient demographics, clinical context, or other factors. 1
• Evidence Gap: There remains a paucity of evidence that AI/ML can positively affect patient outcomes compared with current standards of care. 1

Best Practices for Using MRI Analysis Apps

If using MRI analysis applications, consider these guidelines:

• Use software with CE mark and/or FDA clearance for the specific clinical application. 1, 2
• Understand the magnitude of error in results to help validate findings. 1, 2
• Use the same software and version for longitudinal comparisons. 2
• Consider scanner-related factors and physiological variables that can affect measurements. 2

Common Pitfalls to Avoid

• Overreliance on Automation: Automated tools should supplement, not replace, expert interpretation. 1
• Inadequate Validation: Ensure software has been validated for your specific clinical application. 1, 2
• Inconsistent Protocols: Use standardized measurement protocols across time points. 2
• Software Version Changes: Be aware that updates can affect measurement consistency. 2

In conclusion, while MRI analysis apps can provide valuable assistance in specific contexts, they currently cannot replace the comprehensive interpretation provided by trained radiologists, particularly for complex diagnostic decisions affecting patient morbidity, mortality, and quality of life.