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FerriSmart® Product Specifications
Sensitivity and Specificity
The FerriSmart analysis has high sensitivity and specificity for predicting FerriScan LIC results over the entire LIC range encountered in clinical practice.
| LIC Threshold1 | Clinical Relevance2 | Sensitivity % | Specificity % |
|---|---|---|---|
| 3.0 | Threshold below which deferasirox treatment for non-transfusion dependent thalassemia (NTDT) patients should be interrupted (FDA 2013). |
96% (94-87) |
95% (92-98) |
| 3.2 | Suggested lower limit of optimal range for LICs for chelation therapy in transfusional Fe overload (Olivieri and Brittenham 1997). |
94% (92-96) |
95% (92-98) |
| 5.0 | Threshold above which iron chelation with deferasirox can be considered for patients with NTDT (FDA 2013). |
91% (89-94) |
97% (95-99) |
| 7.0 | Suggested upper limit of optimal range for LICs for transfusional Fe overload and threshold for increased risk of iron-induced complications (Olivieri and Brittenham 1997). Threshold above which deferasirox dose should be increased (to a maximum of 20 mg/kg/day) above the starting dose of 10 mg/kg /day in patients with NTDT (FDA 2013). |
92% (90-95) |
97% (95 - 98) |
| 15 | Threshold for greatly increased risk for cardiac disease and early death in patients with transfusional iron overload (Olivieri and Brittenham 1997). Baseline LIC above which increase of deferasirox dose to 20 mg/kg/day should be considered after first 4 weeks of therapy for NTDT patients (FDA 2013). |
89% (85 - 93) |
98% (98 - 99) |
1 LIC Threshold measured in (mg Fe/g dw).
2 Clinical Relevance taken from Olivieri and Brittenham, Blood 1997; 89:739-61.
2 Clinical Relevance taken from Olivieri and Brittenham, Blood 1997; 89:739-61.
Technical Specifications
Technology
AIA (Deep Artificial Intelligence Assisted) R2-MRI
FerriSmart training and validation
+15,000 inputs of FerriScan R2-MRI results for training, 1,000 for testing and +1,300 inputs of FerriScan R2-MRI results for validation.
Cofounding factors
None from inflammation, fibrosis, fat, scanner make/model and hardware setup
Evaluation
Liver Iron Concentration (LIC)
Longitudinal monitoring capability
Yes
Patient age groups
All
Results generated
In real time
Data acquisition time
5–9 minutes – depending on patient size. Breathhold requirements
None
Contrast agents
None
Slices
11
Data transfer and report delivery system
Via HIPPA &
GDPR compliant secure portal system
GDPR compliant secure portal system Scanner compatibility
Compatible on 1.5T machines, including 
,
, General Electrics and 
others.
,, General Electrics and others. Software requirements
None
Hardware requirements
None specific as long as the required imaging protocol can be achieved
MRI scanner validation
With saline bag
Quality assured certification
ISO 13485:2016
Clearances
FDA 510(k) cleared • 
• 
• ARTG included