FDA Clearance of QuantX SE

Quantitative Insights Joins Fight Against Breast Cancer

Quantitative Insights, Inc. (QI) today announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for its QuantX SE™ system, a quantitative imaging based analysis platform for the evaluation of breast lesions.

“Quantitative Insights is committed to bringing truly disruptive clinical breakthroughs to the fight against breast cancer,” said Keith Tipton, Quantitative Insights’ CEO, “This marks the first of many products to come.”

The company will now pursue product launch activities in the US which include securing several additional Early Adopter sites and pursuing distribution partnerships in the US and select international markets. This groundwork will provide the basis for a major follow-on release of the product which will include advanced machine learning based functionality to further enhance both screening and diagnosis of breast cancer. With the release of QuantX Advanced, expected later this year, the company will launch full scale commercial activities.

“QuantX provides an intuitive, easy to learn and use environment for efficient breast imaging decision support,” commented Gillian Newstead, MD, QI Medical Director and former Chair of Breast Imaging at the University of Chicago. “We’ve waited a long time for a meaningful advancement in breast image analysis. QuantX fills that need.”

Mr. Tipton concluded, “This is one of those defining moments for a young company. We are demonstrating that we can successfully take meaningful clinical innovations from university labs and clinics to the market. Now we will focus on getting QuantX in the hands of clinicians in order to benefit their patients.”

About Quantitative Insights

Quantitative Insights (www.quantinsights.com) 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 functionality. The company’s first product, QuantX™, is a fully-integrated multi-modality breast imaging software solution, providing advanced analytics on MRI data with simultaneous interactive viewing for all three breast image modalities: MRI, mammography and ultrasound.

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