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 ArteraAI Prostate, an AI-enabled software tool designed to assist clinicians in making risk-based decisions for patients with non-metastatic prostate cancer.
ArteraAI Prostate 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 says 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 July, Artera expanded its support for federally qualified health centers (FQHCs), including Bedford-Stuyvesant Family Health Center in Brooklyn and Moses Lake Community Health Center in Washington. FQHCs can now tap into Artera's patient communications platform.
The platform, tailored for FQHCs, supports more than 109 languages, offers automation and leverages EHR data for effective community outreach. It enables patients to contact their healthcare providers through their preferred channels, including text.
In February, Tempus, a company that utilizes AI for precision medicine, and Artera collaborated to commercialize Artera's prostate cancer risk stratification test.
The two companies said the collaboration aims to address the need for more accurate cancer prognostics.
In 2023, Artera partnered with GPT-enabled conversational AI provider Hyro and launched Artera Care Assist. The AI-powered virtual assistant can be embedded into health providers' websites to answer common patient questions.
Artera offers a two-way communication hub for patients and healthcare organizations to connect.
The platform provides multilingual messaging in a patient's preferred communications channel: email, texting, telephone or live chat. Hyro offers a call center for providers that allows for automated conversations with their patients via conversational AI.
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.
The UroNav system features an annotation workflow that supports clinicians during prostate biopsies and focal therapy procedures.
It fuses diagnostic MRI images of the prostate with live ultrasound images for guided procedures in real time. The aim is to help deliver more precise, minimally invasive care.
Viz.ai offers AI-backed imaging and care coordination. In June, the company collaborated with pharma giant Novartis to develop proprietary AI-powered workflows inside the Viz Oncology Suite.
Viz.ai's platform features more than 50 FDA-cleared algorithms that help analyze medical imaging data to provide insights into diagnoses, ease workflows and support treatment decisions.
The companies said they would focus on improving the "identification and stratification of patients diagnosed with prostate and breast cancers based on crucial risk factors, accelerating access to guideline-based precision treatments."
The collaboration also aims to address delays in diagnosis and treatment by utilizing AI to help ensure patients are identified and treated sooner with timely, coordinated care.
