FDA Grants Breakthrough Device Designation to ArteraAI Prostate, an AI Tool for Personalized Prostate Cancer Risk Assessment

Artera, a pioneering precision medicine company, has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) for its AI-powered software, ArteraAI Prostate. This breakthrough designation aims to accelerate the approval and availability of critical tools that guide precision oncology treatment decisions for patients with localized prostate cancer. The Breakthrough Device Designation can significantly speed up the FDA authorization process for ArteraAI Prostate. This software provides personalized risk stratification assessments for patients with localized prostate cancer by analyzing digital pathology images of biopsy slides. It predicts long-term outcomes, such as the 10-year risk of distant metastasis and prostate cancer-specific mortality, helping clinicians choose the most appropriate treatment options. In the U.S., a man is diagnosed with prostate cancer every two minutes, making it the second leading cause of cancer-related deaths among American men. However, there are also 3.5 million men living with the disease, underscoring the varied nature of prostate cancer outcomes and the complexity of matching treatments to the aggressiveness of the disease. Andre Esteva, CEO of Artera, expressed enthusiasm about the designation, stating, “This recognition is a powerful validation of our software's potential to transform cancer care. We are proud that the FDA has acknowledged our innovative technology and excited to advance the field of oncology by delivering clinically relevant tools that can save more lives.” Laura Chang, Senior Vice President of Product at Artera, emphasized the impact of the designation on clinical practice: “This milestone brings us closer to providing actionable insights that can benefit everyone in the cancer journey. Pathologists currently play a crucial role in staging and grading prostate cancer, but ArteraAI Prostate will equip them with advanced risk assessment tools that can be used directly and for the first time in their hands.” The FDA’s Breakthrough Devices Program is designed to fast-track the development and review of medical devices that offer more effective diagnosis or treatment for life-threatening or irreversibly debilitating diseases, ensuring they meet high standards of safety and efficacy. This designation for ArteraAI Prostate highlights the transformative potential of the tool in the field of digital pathology, setting it apart from other AI solutions. While the Breakthrough Device Designation specifically applies to the ArteraAI Prostate medical device, Artera’s broader multimodal artificial intelligence (MMAI) technology platform is already commercially available through its flagship Laboratory Developed Test, the ArteraAI Prostate Test. The company’s laboratory in Jacksonville, Florida, is CLIA-certified and College of American Pathologists (CAP) accredited, ensuring stringent quality and regulatory compliance. ArteraAI Prostate uses a unique algorithm to assess digital images from a patient’s biopsy and combines this with their clinical data to provide both prognostic and predictive insights. This approach has been validated through multiple Phase 3 randomized trials, offering reliable and clinically relevant information. Artera’s commitment to scientific rigor and excellence is reflected in its rapid achievement of key milestones. The company continues to lead the way in delivering advanced AI tools that can fundamentally change how prostate cancer is managed and treated. To learn more about Artera and its groundbreaking AI tests, visit Artera.ai.