FDA Approves ArteraAI Prostate as First AI Tool for Cancer Prognosis

The U.S. Food and Drug Administration has granted De Novo authorization for ArteraAI Prostate, marking a significant milestone in artificial intelligence applications for cancer care. This authorization establishes the software as the first and only AI-powered tool authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer, while creating a new product code category for future AI-powered digital pathology risk-stratification tools.

Developed by Artera, a global leader in precision oncology, the platform represents a breakthrough in multimodal artificial intelligence technology. The system integrates digitized biopsy images with patient clinical data to assess cancer aggressiveness and predict therapy benefit. The technology has been validated across multiple Phase 3 randomized trials and various cancer types, demonstrating its reliability and clinical utility.

ArteraAI Prostate, now recognized as an FDA-regulated Software as a Medical Device (SaMD), offers both prognostic and predictive insights for prostate cancer treatment decisions. The platform was already commercially available in the United States as a laboratory-developed test and internationally through distribution partners before receiving this regulatory approval.

The De Novo authorization brings several key advantages to the platform's implementation. The point-of-diagnosis integration capability enables qualified pathology laboratories throughout the United States to deliver actionable prostate cancer insights at the time of diagnosis, significantly reducing delays in patient care. Additionally, the predetermined change control plan allows for platform expansion to additional digital pathology scanners without requiring new 510(k) submissions, streamlining future technological updates.

The authorization was preceded by Breakthrough Device Designation, which underscored the innovation's clinical significance and potential impact on patient care. This regulatory pathway demonstrates the FDA's recognition of the platform's ability to address unmet medical needs in prostate cancer management.

"This is a defining moment for AI in cancer care," said Andre Esteva, CEO and co-founder of Artera. "The FDA's decision validates our vision to deliver AI-guided tools that enable data-backed, tailored treatments for each patient—enhancing confidence throughout the cancer journey and ultimately saving more lives."

The company has also secured UKCA certification for its ArteraAI Breast Test, ArteraAI Prostate Biopsy Assay, and ArteraAI Prostate, extending the platform's reach across key global markets. This international regulatory approval positions Artera to scale its multimodal artificial intelligence-powered portfolio globally, accelerating the adoption of precision oncology solutions and advancing personalized cancer care standards worldwide.

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