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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.

“Notably, the FDA authorization includes a Predetermined Change Control Plan, granting Artera the ability to expand platform capabilities through validating compatibility with additional digital pathology scanners without requiring further [approval] submissions,” according to Artera, which develops multimodal AI-based prognostic and predictive cancer tests for personalized cancer care.

The De Novo authorization for ArteraAI Prostate followed its July 9 Breakthrough Device Designation and was supported by findings from the STAMPEDE trial and validation data presented at the 2025 American Society of Clinical Oncology (ASCO) conference.

The STAMPEDE trial helped to establish abiraterone, an androgen receptor pathway inhibitor, along with radiation and long-term androgen deprivation therapy, as the standard-of-care treatment for high-risk patients. The validation data presented at ASCO demonstrated the test’s ability to differentiate high-risk patients with nonmetastatic prostate cancer most likely to benefit from abiraterone from those unlikely to benefit.

“For lower-risk patients, the test can help determine if active surveillance is a suitable option, and for intermediate-risk patients, the test can predict if short-term androgen deprivation therapy is beneficial, the company said in a prior statement announcing enhancements that increase the clinical impact for higher-risk patients.

“Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer,” said Nick James, MD, PhD, the lead investigator for STAMPEDE. “We’re excited to now have a test that can pick out the people who will respond best to abiraterone and those who will do well with standard treatment alone.”

Artera also recently announced the launch of a registry trial measuring real-world impact and patient outcomes associated with the tool, which is included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Prostate Cancer.

The NCCN Guideline states that use of the tool for risk stratification of localized prostate cancer in clinical practice is supported by solid evidence. The Category 2A recommendation signifies uniform NCCN consensus that the tool is appropriate for patients with prostate cancer.

“Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer,” said Tim Showalter, MD, radiation oncologist, cancer researcher, and chief medical officer at Artera. “Through the DIRECT-AI registry, we are rigorously evaluating how this technology can enhance clinical decision-making and improve patient outcomes, providing clinicians and patients with the most accurate, tailored insights available.”

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape Medical News, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X @SW_MedReporter.