FDA grants breakthrough device designation for ArteraAI Prostate tool

ArteraAI Prostate was recently granted breakthrough device designation by the FDA, Artera announced in a news release.¹

ArteraAI Prostate is an artificial intelligence (AI) “precision medicine tool intended to assist clinicians with risk-based decisions for patients with localized prostate cancer,” according to the company. It works by analyzing digital pathology images of a prostate cancer biopsy slide to prognosticate factors including 10-year risk of distant metastasis and prostate cancer-specific mortality.

“This designation is a powerful validation of our software's potential to transform how we treat cancer,” said Andre Esteva, CEO of Artera, in the news release. “We’re proud that the FDA has recognized our innovative technology platform, and we’re excited to be advancing the frontier of oncology by delivering differentiated and clinically relevant tools that can help save more lives.”

In the release, Artera noted that the breakthrough device designation specifically pertains to the ArteraAI Prostate medical device, and that the company’s multimodal AI (MMAI) technology platform is currently available for commercial test ordering via the ArteraAI Prostate Test.

“Receiving this designation is a critical step forward in delivering actionable, clinically relevant insights for everyone involved in the cancer journey,” said Laura Chang, SVP of Product at Artera, in the news release. “Today, pathologists play an important role in the staging and grading of prostate cancer, but we believe the addition of ArteraAI Prostate will bring advanced risk assessment tools, which have traditionally been offered as send-out tests, into the hands of pathologists for the first time. While there are other AI tools in digital pathology, this designation for our medical device highlights that what Artera is doing is truly transformative and will empower pathologists to an entirely different level.”

Additional data on the ArteraAI Prostate Test were also recently presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, Illinois.^2,3 Using data from the STAMPEDE trial (NCT00268476), investigators found that the MMAI algorithm could accurately identify which patients with high-risk non-metastatic prostate cancer were most likely to benefit from the addition of abiraterone acetate (Zytiga) plus prednisone to standard of care androgen deprivation therapy. Data showed that continuous MMAI scores were statistically significantly associated with poorer PCSM, (HR, 1.65; 95% CI, 1.43 to 1.90; P < .001), metastasis-free survival (HR, 1.42; 95% CI, 1.29 to 1.56; P < .001), and distant metastasis (HR, 1.54; 95% CI, 1.36 to 1.74; P < .001) in these patients.

Nick James, MD, PhD

“Abiraterone has already hugely improved the outlook for hundreds of thousands of men with advanced prostate cancer,” said Nick James, MD, PhD, lead investigator of the STAMPEDE trial. “We know that for many men with cancer that has not yet spread, it can also have spectacular results. 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 from standard treatment alone—hormone therapy and radiotherapy.”

REFERENCES

1. U.S. FDA grants Artera breakthrough device designation for AI-powered software transforming prostate cancer care. News release. Artera. July 9, 2025. Accessed July 10, 2025.

2. The ArteraAI Prostate Test enhanced with new insights for higher risk patients with localized prostate cancer. News release. Artera. June 5, 2025. Accessed July 10, 2025. https://www.businesswire.com/news/home/20250605022847/en/The-ArteraAI-Prostate-Test-Enhanced-with-New-Insights-for-Higher-Risk-Patients-with-Localized-Prostate-Cancer

3. Parker C, Liu V, Mendes L, et al. Multimodal artificial intelligence (MMAI) model to identify benefit from 2nd-generation androgen receptor pathway inhibitors (ARPI) in high-risk non-metastatic prostate cancer patients from STAMPEDE. J Clin Oncol. 2025;43(suppl 16). doi:10.1200/JCO.2025.43.16_suppl.5001