The risk stratification tool is designed to predict long-term outcomes for patients with non-metastatic prostate cancer.
The US Food and Drug Administration (FDA) has granted De Novo marketing authorization to Artera for ArteraAI Prostate, making it the first AI-powered software authorized to predict long-term outcomes for patients with non-metastatic prostate cancer, according to a release from the company.
The authorization establishes ArteraAI Prostate as an FDA-regulated Software as a Medical Device and creates a new product code category for future AI-powered digital pathology risk-stratification tools. The software can now be implemented at the point of diagnosis in qualified pathology laboratories across the US.
“This is a defining moment for AI in cancer care,” says Andre Esteva, CEO and co-founder of Artera, in a release. “The FDA’s decision validates the power of our MMAI (multimodal artificial intelligence) platform to deliver on our vision to create AI-guided tools that enable data-backed and tailored treatments for each patient, leading to more confidence throughout the cancer journey, and ultimately, save more lives.”
Addressing Workflow Efficiency Challenges
The technology addresses capacity constraints facing pathology laboratories by enabling faster delivery of actionable diagnostic insights. According to pathologists, demand for services continues to outpace available capacity in the field.
“As the demand for pathology services continues to outpace available capacity, tools like ArteraAI Prostate are critical,” says Dr Adam Cole, founder and CSO at TruCore Pathology Group, in a release. “Implementing this software enhances our ability to deliver personalized insights more quickly, improves workflow efficiency, and allows us to scale services while increasing the quality of care.”
The software uses Artera’s multimodal artificial intelligence platform, which analyzes digitized biopsy images along with patient clinical data to determine cancer aggressiveness and predict therapy benefit.
Regulatory Pathway and Future Expansion
De Novo authorization is reserved for novel medical innovations that lack existing regulatory pathways. The authorization includes a Predetermined Change Control Plan, allowing Artera to expand platform capabilities by validating compatibility with additional digital pathology scanners without requiring new 510(k) submissions.
This authorization follows the software’s earlier Breakthrough Device Designation from the FDA. While the De Novo authorization applies specifically to the ArteraAI Prostate medical device software, Artera’s underlying platform remains commercially available as a Laboratory Developed Test through the ArteraAI Prostate Test.
The San Francisco-based company operates a CLIA-certified clinical laboratory in Jacksonville, Florida, and has developed additional AI-powered products including the ArteraAI Breast Test and ArteraAI Prostate Biopsy Assay, both with UKCA authorization in the UK market.
The platform’s approach has been validated in multiple Phase 3 randomized trials across different cancer types, according to the company.
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