Clinical Study Demonstrates Improvement in Reader Performance

As part of the De Novo submission to the FDA, 19 radiologists participated in a clinical study which measured the effectiveness of QuantX™ in distinguishing between cancerous and non-cancerous breast lesions.

The MRMC Clinical Study Demonstrated Improvement in Reader Performance diagnosing breast cancer when QuantX™ is used during Breast MRI interpretation.

 
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reduction in false negatives of 39% without a reduction in specificity.

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20% Overall Diagnostic Improvement

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Performance improved for ALL of the readers in the study.

 

This multiple reader, multiple case (MRMC) clinical study included a sequential reading design. The first read was performed using tools that mimic the tools available on current breast MRI analysis workstations, while the second read consisted of the interpretation of diagnostic breast MR images displayed on the QuantX™ interface with all of the QuantX™ functionality.

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