The US FDA has granted De Novo marketing authorization for ArteraAI Prostate (Artera, Los Altos, California), a novel artificial intelligence (AI)-powered risk-stratification tool for patients with nonmetastatic prostate cancer.
The authorization means the digital pathology software tool is recognized as an FDA-regulated Software as a Medical Device, Artera explained in a press release.
De Novo authorization provides a marketing pathway to classify low-or moderate-risk novel medical devices. The De Novo authorization for this specific test establishes a new product code category for future AI-powered digital pathology risk-stratification tools and enables implementation at the point of diagnosis at qualified US pathology labs, the company said.
The test analyzes digital pathology images from patients’ biopsy slides to predict long-term outcomes, such as 10-year risk for metastasis and mortality. This can help direct treatment decisions.
The FDA’s De Novo authorization for the tool establishes a new product code category for future AI-powered digital pathology risk-stratification tools.