Quantitative Insights said yesterday it won FDA de novo clearance for its QuantX Advanced computer-aided diagnosis platform designed for evaluating breast abnormalities, touting it as the 1st such program to integrate machine learning.
The Chicago-based company said the software platform includes embedded tools, including its QI Score and Similar Case Database Compare, which provide similarity assessment against a “robust database of abnormalities with clinically documented pathology.”
QI said that the system has resulted in a new device Indication for Use through the FDA’s de novo pathway.
“QuantX provides valuable additional information for multi-modality breast imaging decision support. 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,” QI medical advisor Dr. Gillian Newstead said in a press release.
The QuantX platform includes licensed technology from Maryellen Giger’s research labs at The Univeristy of Chicago, which QI said it has had a long-standing collaborative relationship with.
“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,” QI scientific advisor Maryellen Giger of The University of Chicago said in a preapred statement.
The company said it is pursuing a product launch in the US, as well as distribution partners for the US and international markets.
“This clearance marks a true breakthrough in the diagnosis and management of cancers, starting with breast. 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. With QuantX Advanced, we are now ‘all-in’ in the fight against breast cancer,” CEO Keith Tipton said in a prepared statement.