Latest news with #Artera
Yahoo
6 days ago
- Business
- Yahoo
FDA grants de novo authorisation to Artera's prostate software
The US Food and Drug Administration (FDA) has granted de novo authorisation to Artera's ArteraAI Prostate software. This marks it as an inaugural AI-powered software with the ability to predict long-term results for those with non-metastatic prostate cancer. This regulatory milestone categorises ArteraAI Prostate as a software as a medical device (SaMD) and enables the use of such AI-assisted tools in qualified pathology laboratories across the US. The authorisation also sets a new product code for similar future digital pathology risk-stratification applications. The FDA's decision includes a Predetermined Change Control Plan that allows the company to widen its platform by validating compatibility with more digital pathology scanners with no need for additional 510(k) submissions. The test was previously granted a breakthrough device designation by the US regulator. Artera's broader multimodal artificial intelligence (MMAI) platform is already on the market through ArteraAI as a laboratory-developed test (LDT). The MMAI biomarker test of the company utilises an algorithm that evaluates digital biopsy images and clinical data to forecast the efficacy of hormone therapy and estimate long-term patient outcomes. This algorithm is the product of extensive development, drawing from vast datasets, including various patients and pathology slides, and has been clinically validated through several Phase III randomised studies. Artera's portfolio also includes other MMAI-powered products such as the ArteraAI Prostate Biopsy Assay, ArteraAI Prostate, and ArteraAI Breast Test. Artera co-founder and CEO Andre Esteva said: '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.' In February 2025, Artera announced a partnership with Tempus to broaden the availability of the AI-based prostate cancer test. "FDA grants de novo authorisation to Artera's prostate software" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Business Wire
13-08-2025
- Business
- Business Wire
Artera Receives U.S. FDA De Novo Marketing Authorization for AI-Digital Pathology Software Revolutionizing Prostate Cancer Care
SAN FRANCISCO--(BUSINESS WIRE)--Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today that the U.S. Food and Drug Administration (FDA) has granted De Novo authorization for ArteraAI Prostate, establishing it as the first and only AI-powered software authorized to prognosticate long-term outcomes for patients with non-metastatic prostate cancer. ArteraAI Prostate is now recognized as an FDA-regulated Software as a Medical Device (SaMD). The technology's De Novo authorization establishes a new product code category for future AI-powered digital pathology risk-stratification tools, and enables its implementation at the point of diagnosis at qualified pathology labs in the U.S. This capability addresses a critical gap in prostate cancer care by reducing delays in delivering actionable insights at diagnosis, helping clinicians and patients make informed treatment decisions with greater confidence. 'This is a defining moment for AI in cancer care,' said Andre Esteva, CEO and co-founder of Artera. '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.' 'This approval highlights the groundswell of excitement surrounding the incorporation of AI into clinical practice flows. We need to utilize deep learning AI models to augment and better refine what a pathologist is able to report and Artera is leading the charge,' said Dr. Adam Cole, Founder and CSO at TruCore Pathology Group. 'As the demand for pathology services continues to outpace available capacity, tools like ArteraAI Prostate are critical. Implementing this software enhances our ability to deliver personalized insights more quickly, improves workflow efficiency, and allows us to scale services while increasing the quality of care.' Earning FDA De Novo authorization is a rare achievement, designed for novel medical innovations. This accomplishment marks yet another milestone for Artera, spotlighting its leadership and unwavering commitment to scientific rigor and excellence. Notably, the FDA authorization includes a Predetermined Change Control Plan, granting Artera the ability to expand platform capabilities through validating compatibility with additional digital pathology scanners without requiring further 510(k) submissions. The De Novo authorization for ArteraAI Prostate follows its earlier Breakthrough Device Designation. While the De Novo authorization applies specifically to the ArteraAI Prostate medical device software, Artera's underlying MMAI platform is also commercially available through the ArteraAI Prostate Test, as a Laboratory Developed Test (LDT). With this milestone, Artera continues to expand its pipeline of MMAI-powered software to support personalized cancer care. To learn more, visit About Artera Artera is a global leader in precision medicine, leveraging multimodal artificial intelligence (MMAI) to personalize cancer care. Artera's MMAI platform leverages a patient's digitized biopsy images along with the patient's clinical data to determine cancer aggressiveness and predict therapy benefit. This approach has been validated in multiple Phase 3 randomized trials, across different cancers, and is available in multiple versions across the globe. Artera's flagship product, the ArteraAI Prostate Test, is commercially available as a laboratory-developed test in the US and internationally through its distribution partners. The ArteraAI Prostate Test is the first of its kind to deliver both prognostic and predictive insights for patients with prostate cancer, empowering clinicians and patients to make more informed treatment decisions. Additional MMAI-powered products include the ArteraAI Breast Test (UKCA), the ArteraAI Prostate Biopsy Assay (UKCA), and ArteraAI Prostate (FDA). Artera has regulatory authorization for its medical device product in the US and UK. Artera's headquarters is based in Los Altos, California, while its CLIA-certified and clinical laboratory is located in Jacksonville, Florida. For more information about Artera, visit
Business Wire
08-07-2025
- Health
- Business Wire
Groundbreaking AI-Powered Prostate Cancer Treatment Optimization Tool Now Available at Associated Medical Professionals of NY, a U.S. Urology Partners Affiliate in Central New York
SYRACUSE, N.Y.--(BUSINESS WIRE)-- Associated Medical Professionals (A.M.P.) announced today the availability of the ArteraAI Prostate Test, an AI-powered risk stratification tool to help personalize and optimize treatments for patients with localized prostate cancer. Dr. Steven E. Finkelstein, National Director of the Center of Advanced Radiation Excellence (CARE) for U.S. Urology Partners and Director Radiation Oncology Research, helped in the development of the tool and was instrumental in its approval process. Cancer is a scary diagnosis for any patient, but with this new test, we can personalize care and help ensure that the treatments we prescribe will lead to the best outcomes. The low cost and fast turnaround of the test make it much more accessible. Share 'We were excited to be the first in New York to order the ArteraAI Prostate Test for our patients with prostate cancer. Cancer is a scary diagnosis for any patient, but with this new test, we can personalize care and help ensure that the treatments we prescribe will lead to the best outcomes,' said Dr. Steven E. Finkelstein. 'The low cost and fast turnaround of the test make it much more accessible for patients while providing physicians with advanced information to identify optimal treatment plans.' Prostate cancer is the second-leading cause of cancer death in American men, behind only lung cancer. Prostate cancer is a serious disease, but most men diagnosed with prostate cancer do not die from it. More than 3.5 million men in the United States who have been diagnosed with prostate cancer are still alive today, according to the American Cancer Society. Because of the variability in prostate cancer aggressiveness, a major challenge facing clinicians and patients is determining the right treatment options, as both under- and over-treatment can be an issue. The ArteraAI Prostate Test is the only test in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) that can both predict therapy benefit and forecast long-term outcomes in localized prostate cancer. The ArteraAI Prostate Test can increase patients' confidence by offering more clarity around whether they will benefit from a specific treatment course. Dr. Christopher M. Pieczonka, CEO of Associated Medical Professionals of NY, stated, 'The use of multimodal artificial intelligence (MMAI - Artera) is a game changer for New York State patients. This is the only test that has prostate cancer specific mortality as a prognostic endpoint in localized prostate cancer, which enables us to identify the most beneficial treatment plans and provide the highest level of care to our patients.' Artera's multimodal artificial intelligence biomarker test leverages a unique algorithm that assesses digital images from a patient's biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular prostate cancer therapy and has been validated using many Phase 3 randomized trials. About Associated Medical Professionals of NY (A.M.P.) Associated Medical Professionals of New York (A.M.P.) is a medical practice based in Syracuse serving the Central New York region. Established in 2008, A.M.P. has grown to become one of the largest groups of its kind in the area with nine offices and services at 13 hospitals. As a pivotal point of care in each community, A.M.P. is able to provide continuity of care for a vast population of patients. A.M.P. maintains a robust suite of services, including advanced urological care, robotic surgery, cancer care, radiation oncology, interventional radiology, pathology, lithotripsy, imaging and clinical research. For more information about A.M.P., visit About U.S. Urology Partners U.S. Urology Partners offers a comprehensive suite of practice management capabilities to its affiliated community-based urology practices, which maintain their local brand and identity that they have established, often over decades. U.S. Urology Partners currently supports five affiliated groups comprising over 180 providers across practices located in Florida, Indiana, Massachusetts, New York and Ohio. For more information, please visit About Artera Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test. Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera's laboratory in Jacksonville, Florida, and can be ordered online at
Business Wire
17-06-2025
- Business
- Business Wire
Artera Achieves Nationwide Access for its ArteraAI Prostate Test with New York State License
SAN FRANCISCO--(BUSINESS WIRE)-- Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced today it has received its New York laboratory permit from its Department of Health. This licensure allows Artera to offer the award-winning ArteraAI Prostate Test to one of the largest healthcare markets and makes the test available to all patients across the United States. This milestone comes on the heels of Artera's recent announcement that its test is now updated with new insights to help higher-risk patients optimize treatment decisions. This advancement was supported by newly presented validation data, which was selected for Best of ASCO 2025. The ArteraAI Prostate Test is the only test in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) that can both predict therapy benefit and forecast long-term outcomes in localized prostate cancer. Starting on June 4th, clinicians and patients in New York can access data-backed insights to personalize cancer treatment decisions. 'Receiving the New York lab license is a significant milestone for Artera,' said Andre Esteva, CEO and co-founder of Artera. 'Prostate cancer is one of the most common cancers, with the NY State Department of Health estimating that more than 15,000 men are diagnosed each year in New York alone. One of my founding goals was to increase access to AI-enabled precision medicine tools, and I'm proud our team has accomplished this in record time.' New York State inspectors examined laboratory staff qualifications, equipment, facilities, safety program, record, and overall management to ensure the highest standard of care for all laboratory patients. This license follows the College of American Pathologists (CAP) accreditation Artera received in August and the State of California license in October of last year. Together, these certifications underscore Artera's commitment to quality and patient safety. 'We are thrilled that the ArteraAI Prostate Test is now available in New York,' said Himanshu Nagar, MD, Director of Genitourinary Cancer, Department of Radiation Oncology at Memorial Sloan Kettering Cancer Center. 'This test complements existing biomarkers by integrating multimodal AI analysis of both digital pathology and clinical data, providing an additional layer of precision in risk stratification. By leveraging AI-driven insights, it enhances our ability to personalize treatment decisions, ensuring that patients receive the most appropriate therapy while minimizing unnecessary interventions.' About Artera Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test. Artera's multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient's biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials. Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera's laboratory in Jacksonville, Florida, and can be ordered online at
Business Wire
17-06-2025
- Business
- Business Wire
Artera Launches Registry Trial to Measure Real-World Impact and Outcomes of its Prostate Test
SAN FRANCISCO--(BUSINESS WIRE)-- Artera, the developer of multimodal artificial intelligence (MMAI)-based prognostic and predictive cancer tests, announced the launch of its DIRECT-AI registry study. This study will assess how the ArteraAI Prostate Test influences treatment decision-making between clinicians and patients with localized prostate cancer. Additionally, the study will monitor participants to evaluate their long-term cancer outcomes, reinforcing Artera's commitment to advancing personalized cancer treatment and identifying future opportunities for test optimization. The DIRECT-AI study centers on the award-winning ArteraAI Prostate Test—the only test included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) for localized prostate cancer that can both predict therapy benefit and prognosticate long-term outcomes. "Harnessing the power of AI, the ArteraAI Prostate Test marks a significant advancement in the personalized treatment of localized prostate cancer. Through the DIRECT-AI registry, we are rigorously evaluating how this technology can enhance clinical decision-making and improve patient outcomes, providing clinicians and patients with the most accurate, tailored insights available," said Dr. Tim Showalter, Chief Medical Officer at Artera. The study is structured into two phases. The initial phase captures real-world insights into how the Artera Prostate Test informs clinical decision-making, with feedback collected from participating clinicians and patients. The second phase will monitor long-term health outcomes at key intervals of 2 and 5 years, looking at endpoints such as distant metastasis, survival rates, and treatment effectiveness. This research will help Artera understand how its test impacts cancer outcomes and monitor its performance so that it can be improved for patients in the future. Any patient receiving the commercial ArteraAI Prostate Test and whose ordering physician is associated with an enrolling clinic is eligible to participate in the study. Patients must have localized prostate cancer and must not have started or received treatment for their condition. The study is non-interventional, meaning it does not require additional procedures or tests, and there will be no changes to the care participants receive, regardless of their participation. For clinics participating in the DIRECT-AI Registry, physicians can enroll all patients for whom they order an ArteraAI Prostate Test in the study. For more information and to sign up, visit the website or contact direct-ai@ About Artera Artera is a leading precision medicine company developing AI tests to personalize cancer therapy. Artera offers an AI-enabled test that is the first of its kind to provide both prognostic and predictive results for patients with localized prostate cancer: ArteraAI Prostate Test. Artera's multimodal artificial intelligence (MMAI) biomarker test leverages a unique algorithm that assesses digital images from a patient's biopsy and their clinical data. The AI combines this information to determine their prognosis and predict whether a patient will benefit from a particular therapy and has been validated using many Phase 3 randomized trials. Artera's laboratory is CLIA-certified and College of American Pathologists (CAP) accredited. The ArteraAI Prostate Test is clinically available through Artera's laboratory in Jacksonville, Florida, and can be ordered online at
