Artera Receives U.S. FDA De Novo Marketing Authorization for AI-Digital Pathology Software Revolutionizing Prostate Cancer Care
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 Artera.ai.
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 artera.ai.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
21 minutes ago
- Yahoo
FluMist, a vaccine nasal spray, is now available for use at home
Those looking to protect themselves against the flu this season now have an at-home option. FluMist, the only nasal spray flu vaccine approved by the Food and Drug Administration, is now available for purchase for self-administration. AstraZenca's FluMist was approved in 2003 to be given by health care providers. Last year, the FDA broadened the approval of the nasal spray to make it the first self-administered option. An at-home delivery service, called FluMist Home, will be available in 34 states this flu season. Through FluMist Home, customers can get the same FluMist nasal spray — shipped to their homes — that patients can receive at a doctor's office or pharmacy. How much does FluMist cost? According to the online ordering platform, FluMist is free under most commercial insurance. There is, however, a fee of $8.99 for shipping and processing. To order, customers have to give some basic personal information, medical details, insurance information and a payment method. Who can use FluMist at home? FluMist is approved for at-home use for those ages 2 to 49, but a caregiver should administer FluMist to individuals 2 through 17, according to the website. The website includes instructions on how to administer the spray to yourself and family members. FluMist should not be used in people with "a severe allergy to its components, eggs or other flu vaccines," according to the product's website, which offers a full list of patient and safety information. What states is FluMist Home available in? According to a news release, FluMist Home will be available in the following states for the 2025-2026 flu season: AlabamaArizonaCaliforniaColoradoConnecticutFloridaGeorgiaIowaIdahoIllinoisMassachusettsMarylandMaineMichiganMontanaNorth CarolinaNorth DakotaNebraskaNew HampshireNew JerseyNevadaOhioOregonPennsylvaniaSouth CarolinaSouth DakotaTennesseeTexasUtahVirginiaVermontWashingtonWisconsinWyoming "There are a number of states where FluMist Home is unavailable due to local pharmacy laws," the release notes. "Our aim is to have this service available in all 48 contiguous states in future seasons." Passenger arrested after allegedly causing disturbance midair and forcing flight to divert When could Tropical Storm Erin become a hurricane? Urban garden helps combat food insecurity in Miami Solve the daily Crossword
Business Wire
22 minutes ago
- Business Wire
The Future Isn't Predicted — It's Declared: Vanto Group Launches Leadership Masterclass to Transform How Executives Shape Tomorrow
FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Vanto Group, recognized by Forbes as one of the World's Best Management Consulting Firms, announces the launch of Forward From the Future, a year-long premier leadership immersion designed for senior leaders navigating unprecedented complexity, challenging decisions, and uncertainty in business and society. Forward From the Future equips leaders to design and lead from a future of their own making. Share In an era where traditional models for decision-making, forecasting, and risk management are no longer sufficient, Forward From the Future equips leaders to design and lead from a future of their own making—one that is informed by the past but not limited by it or current circumstances. Over the course of 12 months, participants will: Achieve Breakthrough Results — Move beyond incremental improvement to lasting, high-impact outcomes. Expand Leadership in Uncertainty — Create coordinated action in the midst of complexity. Lead from Declaration, Not Circumstance — Act from a future vision rather than default patterns. Disrupt Automatic Responses Under Pressure — Access greater presence and choice. Align and Enroll at Scale — Build unity across cultural, generational, and functional boundaries. Use Language as a Strategic Asset — Elicit ownership, commitment, and shared futures. Navigate Complex Networks — See organizations as living networks of conversations driving performance. Join a Peer Group That Elevates — Collaborate with a select cohort of senior leaders committed to shaping what's next. Structure: Location: Round Top, Texas Format: In-person gatherings + live leadership projects Duration: 12 months Includes four in-person immersive gatherings, one live high-stakes leadership project, and ongoing coaching and integration. With over 30 years of experience catalyzing enduring shifts in organizational performance, Vanto Group's approach is immersive and partnership-driven—cutting through complexity and awakening what's possible for leaders and their organizations. Applications are now open for senior leaders ready to go beyond optimizing the past and create breakthrough futures. For more information and to apply, visit here.
Associated Press
22 minutes ago
- Associated Press
Competitive Analysis of The Middleby Corp, Electrolux, Illinois Tool Works, Dover, Hoshizaki , Ali Group, Duke Manufacturing
DUBLIN--(BUSINESS WIRE)--Aug 15, 2025-- The 'Global Cloud Kitchen Food Service Equipment Market (2025 Edition): Analysis By Equipment Type, By End-User, By Kitchen Type, By Region, By Country: Market Insights and Forecast (2021-2031)' report has been added to offering. The Global Cloud Kitchen Food Service Equipment market showcased growth at a CAGR of 13.56% during 2021-2024. The market was valued at USD 59.56 Billion in 2024 which is expected to reach USD 152.17 Billion in 2031. This report provides a complete analysis for the historical period of 2021-2024, the estimates of 2025 and the forecast period of 2026-2031. The Cloud Kitchen Food Service Equipment Market is operating and growing rapidly, driven by a convergence of technological innovation, evolving consumer preferences, and strategic economic factors. At its core, this market encompasses a wide array of equipment specifically designed to enhance the efficiency, safety, and scalability of cloud kitchens - facilities that prepare food solely for delivery or takeaway without a traditional dine-in option. Key equipment categories include cooking appliances like convection ovens, grills, and fryers; refrigeration units for optimal food storage; food preparation tools such as mixers and slicers; packaging equipment for efficient and safe food handling; and warewashing systems to maintain hygiene standards. The integration of cutting-edge technologies is a major driver of growth in this market. AI-driven kitchen automation systems streamline operations, from order management to food preparation, ensuring consistency and reducing human error. IoT-enabled devices provide real-time monitoring and control, enhancing efficiency and predictive maintenance. Additionally, advancements in robotics are revolutionizing food preparation and packaging processes, leading to faster service and improved safety standards. These technological advancements not only boost operational efficiency but also enable cloud kitchens to meet the high expectations of tech-savvy consumers. Additionally, consumer preferences have shifted significantly towards convenience, speed, and variety, fueling the demand for cloud kitchens. The rise of digital platforms for food ordering and delivery has created a robust market for these establishments, which can quickly adapt to changing tastes and dietary trends. Health-conscious consumers, for instance, are driving demand for equipment that supports the preparation of fresh, nutritious meals. Cloud kitchens can offer diverse and customizable menus without the limitations of traditional restaurant setups, catering to niche markets and specific dietary requirements. Moreover, the economic advantages of cloud kitchens are substantial, contributing to their proliferation and the subsequent demand for specialized equipment. Lower overhead costs compared to traditional restaurants - due to savings on real estate, labor, and front-of-house expenses - make cloud kitchens an attractive investment. This economic model allows for greater flexibility and scalability, enabling operators to quickly expand their reach and experiment with new culinary concepts. Furthermore, the cost efficiency of cloud kitchens appeals to entrepreneurs and established food service brands looking to optimize their operations and maximize profitability. Subsequently, sustainability is an increasingly important factor in the growth of the cloud kitchen equipment market. There is a growing emphasis on energy-efficient appliances and eco-friendly packaging solutions to meet regulatory standards and consumer expectations. Equipment manufacturers are innovating to provide greener solutions, such as low-energy consumption ovens, recyclable packaging materials, and advanced waste management systems. These sustainable practices not only reduce environmental impact but also resonate with environmentally conscious consumers, enhancing brand reputation and customer loyalty. Furthermore, collaborative partnerships between equipment manufacturers, technology providers, and food service operators are pivotal in driving market expansion and innovation. These collaborations facilitate the development of tailored solutions that address the specific needs of cloud kitchens, from space optimization to multi-functional equipment designs. Additionally, strategic alliances with logistics and delivery platforms enhance operational efficiency and customer satisfaction. The market is also witnessing significant investments from venture capitalists and private equity firms, further propelling growth and innovation. Scope of the Report Analyst Recommendations Competitive Positioning Company Profiles For more information about this report visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: FOOD TECH RETAIL IOT (INTERNET OF THINGS) TECHNOLOGY SPECIALTY ARTIFICIAL INTELLIGENCE FOOD/BEVERAGE SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 08/15/2025 11:18 AM/DISC: 08/15/2025 11:18 AM
