21 Oct ACG 2022 Annual Scientific Meeting, Charlotte, North Carolina

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LiverSmart® Product Specifications

Sensitivity and Specificity

The FerriScan analysis has the highest sensitivity and specificity over the entire LIC range encountered in clinical practice compared to any other method of LIC determination.

LIC Threshold1 Clinical Relevance2 Sensitivity % Specificity %
1.8 The upper 95% limit of normal LIC (Bassett et al. 1986). 96%
(94 - 97)
(73 - 87)
3.0 Threshold below which deferasirox treatment for non-transfusion dependent thalassemia (NTDT) patients should be interrupted (FDA 2013). 96%
3.2 Suggested lower limit of optimal range for LICs for chelation therapy in transfusional Fe overload (Olivieri and Brittenham 1997). 94%
5.0 Threshold above which iron chelation with deferasirox can be considered for patients with NTDT (FDA 2013). 91%
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%
(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 - 99)
1 LIC Threshold measured in (mg Fe/g dw).
2 Clinical Relevance taken from Olivieri and Brittenham, Blood 1997; 89:739-61.

Technical Specifications


AIA (Deep Artificial Intelligence Assisted) R2-MRI

FerriSmart training and validation

+20,000 inputs of FerriScan R2-MRI results for training and +2,000 inputs of FerriScan R2-MRI results for validation

Cofounding factors

None from inflammation, fibrosis, fat, scanner make/model and hardware setup


Liver Iron Concentration (LIC)

Longitudinal monitoring capability


Patient age groups

All including neonates

Results generated

In real time

Scan time

5–9 minutes – depending on patient size.

Breathhold requirements


Contrast agents




Data transfer and report delivery system

Via HIPPA & GDPR compliant secure portal system

Scanner compatibility

Compatible on 1.5T machines, including ,, General Electrics and others.

Software requirements


Hardware requirements

None specific as long as the required imaging protocol can be achieved

MRI scanner validation

With FerriSmart Phantom pack

Quality assured certification

ISO 13485:2016


FDA 510(k) cleared