FDA De Novo For QuantX Advanced

Quantitative Insights Gains Industry’s First FDA Clearance for Machine Learning Driven Cancer Diagnosis

Quantitative Insights, Inc. (QI) recently announced that it 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.

“This clearance marks a true breakthrough in the diagnosis and management of cancers, starting with breast,” said Keith Tipton, CEO of Quantitative Insights, “In our FDA clinical study, QuantX was shown to improve the diagnostic performance of radiologists, enabling faster and more accurate diagnosis, more personalized treatments, and better outcomes for patients.”

QuantX is a software platform, with advanced analytics and machine learning at its core. Embedded exclusive tools – QI Score and Similar Case Database Compare – provide similarity assessment to a robust database of abnormalities with clinically documented pathology. This first-of-a-kind system has resulted in a new device Indication for Use via the FDA’s de novo regulatory pathway.

“QuantX provides valuable additional information for multi-modality breast imaging decision support,” states Gillian Newstead, M.D., QI Medical Advisor and former Chief of Breast Imaging at the University of Chicago. “With a single click, we have access to advanced machine learning analytics showing how the abnormality being analyzed compares to similar abnormalities with known pathology. This impacts a radiologist’s confidence and improves reading time, and now we have clinical-study proof that it also significantly improves diagnostic performance.”

QuantX incorporates licensed technology from the research labs of Maryellen Giger, Ph.D., Scientific Advisor for the company and professor in Radiology and Medical Physics at The University of Chicago. Giger states, “Quantitative Insights has demonstrated that they can successfully take meaningful clinical innovations from research labs and clinics, develop them into products, take them through the regulatory process, and to the market.” The company has a long-standing collaborative relationship with the university and is supported by the university’s Polsky Center for Entrepreneurship and Innovation.

The company will now pursue its product launch activities in the U.S., which includes expansion of strategic collaborations with clinical researchers. The company is also pursuing distribution partnerships for both the U.S. and international markets. Mr. Tipton concluded, “With QuantX Advanced, we are now ‘all-in’ in the fight against breast cancer.”

About Quantitative Insights
Quantitative Insights is dedicated to redefining patient management by harnessing the power of cutting-edge research and advanced quantitative imaging solutions to provide radiologists with intuitive computer-aided decision support tools. The company’s flagship product, QuantX, is a software platform solution for machine learning and deep learning quantitative imaging (or radiomics) solutions. QuantX includes technology licensed from The University of Chicago. The company is supported by the university’s Polsky Center for Entrepreneurship and Innovation.