The software is said to predict long-term results for those with non-metastatic prostate cancer. Credit: Chinnapong / Shutterstock.com.

The US Food and Drug Administration (FDA) has granted de novo authorisation to Artera’s ArteraAI Prostate software.

This marks it as an inaugural AI-powered software with the ability to predict long-term results for those with non-metastatic prostate cancer.

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This regulatory milestone categorises ArteraAI Prostate as a software as a medical device (SaMD) and enables the use of such AI-assisted tools in qualified pathology laboratories across the US.

The authorisation also sets a new product code for similar future digital pathology risk-stratification applications.

The FDA’s decision includes a Predetermined Change Control Plan that allows the company to widen its platform by validating compatibility with more digital pathology scanners with no need for additional 510(k) submissions.

The test was previously granted a breakthrough device designation by the US regulator.

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Artera’s broader multimodal artificial intelligence (MMAI) platform is already on the market through ArteraAI as a laboratory-developed test (LDT).

The MMAI biomarker test of the company utilises an algorithm that evaluates digital biopsy images and clinical data to forecast the efficacy of hormone therapy and estimate long-term patient outcomes.

This algorithm is the product of extensive development, drawing from vast datasets, including various patients and pathology slides, and has been clinically validated through several Phase III randomised studies.

Artera’s portfolio also includes other MMAI-powered products such as the ArteraAI Prostate Biopsy Assay, ArteraAI Prostate, and ArteraAI Breast Test.

Artera co-founder and CEO Andre Esteva said: “The FDA’s decision validates the power of our MMAI 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.”

In February 2025, Artera announced a partnership with Tempus to broaden the availability of the AI-based prostate cancer test.

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