FDA grants Breakthrough Device Designation to ArteraAI Prostate Tool

New device aims to help prostate cancer evaluation: ©Dr. Microbe - stock.adobe.com

The U.S. Food and Drug Administration has granted Breakthrough Device Designation to ArteraAI Prostate, an artificial intelligence-based precision medicine tool developed by Artera to support treatment decisions for patients with localized prostate cancer.

The designation aims to expedite the FDA review process for the software, which analyzes digital pathology images from biopsy slides to help clinicians assess a patient's long-term risk of distant metastasis and prostate cancer-specific mortality. ArteraAI Prostate is designed to offer personalized prognostic insight to help determine the most appropriate care strategy for individual patients.

“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.”

Prostate cancer is the second leading cause of cancer death among American men. A new diagnosis occurs approximately every two minutes in the U.S., but outcomes vary widely, with over 3.5 million men currently living with the disease.

Laura Chang, senior vice president of product at Artera, noted the tool’s ability to empower pathologists directly. “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.”

ArteraAI Prostate is the first AI-driven risk stratification tool for prostate cancer to receive the FDA’s Breakthrough Device Designation.

AI’s growing role in personalized cancer diagnostics

Artificial intelligence is playing an increasingly critical role in the evolution of precision oncology, particularly in the realm of digital pathology and diagnostic decision support. As diagnostic technologies move toward greater personalization, AI tools are helping clinicians navigate complex data to identify more accurate prognoses and treatment pathways for patients.

Recent advancements in this sector are marked by the integration of multimodal data sources—including digital pathology slides, radiology scans, genomic profiles, and clinical records—into AI platforms that can identify subtle patterns unrecognizable to the human eye. These tools are accelerating early diagnosis, refining risk stratification, and reducing overtreatment by helping determine which patients are likely to benefit from aggressive therapy and which are better served with active surveillance.

One of the most notable developments is the movement of diagnostic capabilities from centralized labs to the point of care. AI-enabled software is beginning to allow hospitals and pathology labs to access advanced decision support tools in real time, instead of sending samples to external facilities for genomic testing. This not only shortens turnaround time but also has the potential to reduce health care costs and expand access to advanced diagnostics in community settings.

In addition, AI’s role in predictive modeling is becoming a valuable asset in shared decision-making. By quantifying the long-term risks associated with various treatment options, these tools are helping patients and clinicians weigh choices more confidently, aligning care with individual values and clinical needs.

With regulatory pathways like the FDA’s Breakthrough Devices Program accelerating the adoption of innovative AI tools, experts anticipate rapid growth in AI-enabled cancer diagnostics across a range of tumor types, with the potential to redefine clinical workflows and improve patient outcomes.