Artera’s AI-Powered Software for Prostate Cancer Earns FDA Breakthrough Nod

Artera, a developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, has received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its ArteraAI Prostate test.

ArteraAI Prostate is an AI precision medicine tool to help clinicians with risk-based decisions for patients with localized prostate cancer. The software generates a personalized risk stratification assessment for localized prostate cancer patients.

The tool analyzes digital pathology images of a prostate cancer biopsy slide to prognosticate long-term outcomes like ten-year risk of distant metastasis and prostate-cancer specific mortality to help clinicians decide the most appropriate treatment option.

The software, according to the company, is the first and only AI-powered risk stratification tool for prostate cancer to earn FDA breakthrough device status. This follows multiple milestones that Artera has achieved.

“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.”

“Receiving this designation is a critical step forward in delivering actionable, clinically relevant insights for everyone involved in the cancer journey,” added 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.”