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FDA grants regulatory clearance to QuantX for breast cancer diagnosis
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The FDA granted regulatory clearance to the QuantX Advanced system, a computer-aided diagnosis platform that evaluates breast abnormalities, according to the device’s manufacturer.
“This clearance marks a true breakthrough in the diagnosis and management of cancers, starting with breast,” Keith Tipton, CEO of Quantitative Insights, said in a company-issued release. “In our FDA clinical study, QuantX [Quantitative Insights] was shown to improve the diagnostic performance of radiologists, enabling faster and more accurate diagnosis, more personalized treatments and better outcomes for patients.”
The QuantX Advanced system incorporates the QI Score and Similar Case Database Compare tools to provide similarity assessment to a robust database of abnormalities with clinically documented pathology.
“QuantX provides valuable additional information for multimodality breast imaging decision support,” Gillian Newstead, MD, medical advisor at Insights and former chief of breast imaging at University of Chicago, said in the press release. “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."
Quantitative Insights plans to expand its strategic collaborations and to pursue distribution partnerships for both the U.S. and international markets, according to the release.
“With QuantX Advanced, we are now 'all-in' in the fight against breast cancer,” Tipton said.