U.S. FDA Grants Artera Breakthrough Device Designation for AI-Powered Software Transforming Prostate Cancer Care

July 09, 2025 at 09:00 AM EDT

Revolutionary designation accelerates access to critical insights guiding on-the-ground treatment decisions in precision oncology

Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to ArteraAI Prostate, an AI precision medicine tool intended to assist clinicians with risk-based decisions for patients with localized prostate cancer.

Breakthrough Device Designation may expedite the FDA authorization process for the ArteraAI Prostate software, which provides a personalized risk stratification assessment for patients with localized prostate cancer. ArteraAI Prostate analyzes digital pathology images of a patient’s prostate cancer biopsy slide to prognosticate long-term outcomes, such as 10-year risk of distant metastasis and prostate-cancer specific mortality, to help clinicians determine the most appropriate treatment option.

A man is diagnosed with prostate cancer every 2 minutes in the U.S. While it is the second leading cause of cancer death among American men, there are also 3.5 million men in the U.S. living with the disease today. These staggering statistics highlight the wide range of outcomes and the ongoing challenges of matching treatment to cancer aggressiveness.

“This designation is a powerful validation of our software's potential to transform how we treat cancer,” said Andre Esteva, CEO of Artera. “We’re proud that the FDA has recognized our innovative technology platform, and we’re excited to be advancing the frontier of oncology by delivering differentiated and clinically relevant tools that can help save more lives.”

ArteraAI Prostate is the first, and currently only, AI-powered risk stratification tool for prostate cancer to receive FDA Breakthrough Device Designation. This designation comes on the heels of multiple milestones achieved by Artera, reinforcing its leadership in driving scientific rigor and excellence.

“Receiving this designation is a critical step forward in delivering actionable, clinically relevant insights for everyone involved in the cancer journey,” said Laura Chang, SVP of Product at Artera. “Today, pathologists play an important role in the staging and grading of prostate cancer, but we believe the addition of ArteraAI Prostate will bring advanced risk assessment tools, which have traditionally been offered as send-out tests, into the hands of pathologists for the first time. While there are other AI tools in digital pathology, this designation for our medical device highlights that what Artera is doing is truly transformative and will empower pathologists to an entirely different level.”

The FDA’s Breakthrough Devices Program is designed to accelerate the development and review of medical devices that offer more effective diagnosis or treatment for serious conditions, while maintaining rigorous standards for safety and effectiveness. While the Breakthrough Designation is specific to the ArteraAI Prostate medical device, Artera’s underlying MMAI technology platform is available for commercial test ordering through its flagship Laboratory Developed Test, the ArteraAI Prostate Test. To learn more, visit Artera.ai.

About Artera

Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test.

Artera’s multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient’s biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials.

Artera’s laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera’s laboratory in Jacksonville, Florida, and can be ordered online at Artera.ai.