• First FDA Clearance for Machine Learning Driven Cancer Diagnosis

    Quantitative Insights, Inc. (QI) has received regulatory clearance (via De Novo classification) from the U.S. Food and Drug Administration (FDA) for its QuantX™ Advanced system, the industry’s first computer-aided diagnosis platform incorporating machine learning for the evaluation of breast abnormalities.

    QuantX™ is a software platform, with advanced analytics and machine learning at its core. This first-of-a-kind system has resulted in a new device Indication for Use via the FDA’s de novo regulatory pathway.

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  • Successful Study!

    The study’s primary endpoint was achieved with statistical significance.

    A total of 19 readers completed the study which demonstrated a statistically significant increase in radiologist’s performance when compared to interpretations using the tools available in existing commercial systems. Performance improved for all of the readers in the study, and the study demonstrated a reduction in false negatives (i.e. missed cancers) by 39%.

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  • Machine Learning in Radiology

    Combining machine learning and a big data derived historic reference case database.

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  • Quantitative Insights, Inc. (QI) was formed to realize the clinical and commercial value of QuantX, a Computer-Aided Diagnosis system to aid Radiologists in more accurate diagnosis of breast cancer. Developed in the labs and clinics of the University of Chicago to improve outcomes while, at the same time, significantly reducing costs, QuantX addresses critical needs of clinicians, practice administrators and patients… Read More

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