California-based Artera has received de novo authorization from the U.S. Food and Drug Administration (FDA) for its artificial intelligence platform designed to predict long-term outcomes in prostate cancer patients.
The technology, called ArteraAI Prostate, is intended to support clinicians in making personalized, risk-based treatment decisions for individuals with non-metastatic prostate cancer. The platform analyzes digital images of biopsy slides to forecast key outcomes, including a patient’s 10-year risk of distant metastasis and prostate cancer-specific mortality.
Just last month, the company’s tool was awarded Breakthrough Device Designation by the FDA, underscoring its potential clinical impact. Artera says the approval represents a significant step toward closing gaps in prostate cancer care by providing critical insights at the time of diagnosis.
“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,” said Artera cofounder and CEO Andre Esteva in a statement.
According to the Centers for Disease Control and Prevention, more than 255,000 new cases of prostate cancer were reported in the U.S. in 2022, and nearly 34,000 men died of the disease in 2023. The prevalence of prostate cancer highlights the growing demand for innovative tools that can improve care and survival outcomes.
Artera has been expanding its footprint in cancer care throughout the past year. In July, the company extended support for federally qualified health centers (FQHCs), enabling clinics such as Bedford-Stuyvesant Family Health Center in Brooklyn and Moses Lake Community Health Center in Washington to use its patient communications platform.
Earlier this year, Artera partnered with Tempus, a precision medicine company leveraging AI, to commercialize its risk stratification test. In 2023, it also teamed up with GPT-enabled conversational AI provider Hyro to launch Artera Care Assist, a multilingual virtual assistant that integrates with health provider websites to address common patient questions via email, text, phone, or live chat.
Artera joins a growing list of companies applying AI to prostate cancer care. Royal Philips recently received FDA 510(k) clearance for its latest image-guided navigation system, while Viz.ai partnered with Novartis in June to build AI-powered oncology workflows into its Viz Oncology Suite.
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