Editor's note: The Larger Trend section has been updated.
California-based Artera, a company that develops multimodal AI-based prognostic and predictive cancer tests, has been granted de novo authorization by the FDA for its AI tool for prostate cancer prognosis.
ArteraAI Prostate is an AI platform designed to assist clinicians in making risk-based decisions for patients with non-metastatic prostate cancer.
The tool examines digital pathology images of a patient’s prostate cancer biopsy slide to forecast long-term outcomes, such as a 10-year risk of distant metastasis and prostate cancer-specific mortality.
Last month, the company received Breakthrough Device Designation by the FDA for the same product.
The company states the offering aims to reduce gaps in prostate cancer care by delivering advice at 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," Andre Esteva, CEO and cofounder of Artera, said in a statement.
THE LARGER TREND
According to the Centers for Disease Control and Prevention, 255,395 new prostate cancers were reported in the U.S. in 2022 and 33,881 males died from prostate cancer in 2023.
In February, Tempus, a company that utilizes AI for precision medicine, and Artera collaborated to commercialize Artera's prostate cancer risk stratification test.
The platform provides multilingual messaging in a patient's preferred communications channel: email, texting, telephone or live chat.
Other companies in the prostate cancer space include Royal Philips, which in July announced it received FDA 510(k) clearance for its latest image-guided navigation system for prostate cancer.
Viz.ai offers AI-backed imaging and care coordination, and in June, the company collaborated with pharma giant Novartis to develop proprietary AI-powered workflows inside the Viz Oncology Suite.
