AI for Breast Cancer Diagnosis: The First FDA Cleared System Is Here

In In The News by Barbara Jacoby



From apps that scan for sun damage to devices that restore eyesight, Artificial Intelligence (AI) is changing how we approach healthcare. The latest in this ever-growing list: AI for breast cancer diagnosis.

QuantX, created by Paragon Biosciences and Qlarity Imaging, is an AI-based breast cancer diagnosis system. It is the first ever cleared by the FDA.

Meant for use as an aid, not a replacement, to radiologists, QuantX is an effective tool in interpreting MRIs and analyzing differences between cancerous and noncancerous lesions.

In a clinical study, QuantX led to a 39 percent reduction in missed breast cancers and a 2 percent overall diagnostic improvement. Additionally, all 19 radiologists who participated in the study reported improved performance with QuantX.

“We believe the future is radiologists with technology,” Jeffrey Aronin, chairman and CEO of Paragon Biosciences said in a Fast Company article.

This future may very well look like a less anxiety provoking diagnostic process for millions of women and men.

Per Meghan Harrison, head of product and COO at Qlarity Imaging, 75 percent of biopsies for women with suspicious screener findings come back negative, but only after a stressful wait time.

“We believe that Qlarity can do better, help radiologists make better diagnoses with our software,” she said in the Fast Company article. “We can help them deliver better patient care.”

Patients’ whose findings do come back positive may also have a better eventual outcome, as early detection is key in treating breast cancer.