FDA Gives Breakthrough Device Status to 4D Path’s Breast Cancer Diagnostic Platform


The U.S. Food and Drug Administration (FDA) has designated 4D Path’s software a breakthrough device as a possible way to achieve a faster and more accurate breast cancer diagnosis based on tissue taken in a breast biopsy or resection. Named 4D Q-plasia OncoReader Breast, the software is intended to aid doctors in evaluating biopsies and resections (tumors that are surgically removed), and in achieving a more accurate diagnosis.

“We are thrilled that the FDA has recognized the potential of our technology to offer significant advantages over existing approved or cleared alternatives to establish long-term clinical efficiencies. Our device acts on par with a diagnostic histopathologist in the identification of invasive cancer," Nic Orsi, PhD, chief pathologist for 4D Path, said in a press release.

Breakthrough device status is given to medical technologies that may lead to more effective diagnosis or treatment for life-threatening or debilitating conditions. Read the article in Breast Cancer News here.