Artera has received the US Food and Drug Administration (FDA) De Novo authorisation for its AI-driven digital pathology software, ArteraAI Prostate.
Now recognised as a regulated software-as-a-medical device (SaMD), the tool employs a unique algorithm to assess biopsy images and clinical data
It is said to advance prostate cancer care by offering critical insights that support treatment decisions.
ArteraAI Prostate uses a multimodal artificial intelligence (MMAI) approach to analyse digitised biopsy images and clinical data to evaluate cancer aggressiveness and predict therapy benefits.
The approach has been validated through multiple Phase 3 randomised trials.
ArteraAI Prostate is the first AI-powered tool to offer both prognostic and predictive insights for non-metastatic prostate cancer patients, according to Artera.
Artera CEO and co-founder 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.”
The De Novo authorisation for ArteraAI Prostate follows a previous Breakthrough Device Designation from the FDA.
It establishes a new product code category for future AI-powered digital pathology tools, facilitating their implementation at qualified pathology labs across the US.
The recent authorisation includes a Predetermined Change Control Plan, allowing Artera to expand platform capabilities by validating compatibility with additional digital pathology scanners without needing further 510(k) submissions.
The ArteraAI Prostate Test is available in the US through Artera’s CLIA-certified laboratory in Jacksonville, Florida, and internationally via distribution partners.
It can be used for patients across all National Comprehensive Cancer Network (NCCN) risk groups, providing insights into ten-year risks of distant metastasis and prostate cancer-specific mortality.
TruCore Pathology Group founder and CSO Adam Cole said: “This approval highlights the groundswell of excitement surrounding the incorporation of AI into clinical practice flows.
“We need to utilise deep learning AI models to augment and better refine what a pathologist is able to report, and Artera is leading the charge.
“As the demand for pathology services continues to outpace available capacity, tools like ArteraAI Prostate are critical.
“Implementing this software enhances our ability to deliver personalised insights more quickly, improves workflow efficiency, and allows us to scale services while increasing the quality of care.”
