BioPharmaTrend
Latest News
All Topics
  • Artificial Intelligence
  • NeuroTech
  • Premium Content
  • Knowledge Center
Interviews
Companies
  • Company Directory
  • Sponsored Case Studies
  • Create Company Profile
More
  • About Us
  • Our Team
  • Advisory Board
  • Citations and Press Coverage
  • Partner Events Calendar
  • Advertise with Us
  • Write for Us
Subscribe
Login/Join

  Latest News

FDA Grants De Novo Authorization to ArteraAI’s Multimodal AI Prostate Cancer Risk Software

by Anastasiia Rohozianska  (contributor )   •   Aug. 14, 2025  

Disclaimer: All opinions expressed by Contributors are their own and do not represent those of their employers, or BiopharmaTrend.com.
Contributors are fully responsible for assuring they own any required copyright for any content they submit to BiopharmaTrend.com. This website and its owners shall not be liable for neither information and content submitted for publication by Contributors, nor its accuracy.

# AI & Digital   
Share:   Share in LinkedIn  Share in Bluesky  Share in Reddit  Share in Hacker News  Share in X  Share in Facebook  Send by email

The U.S. Food and Drug Administration has granted De Novo authorization to ArteraAI Prostate, a multimodal artificial intelligence (MMAI) software developed by Artera, Los Altos, California headquartered precision medicine company, designed to assist clinicians with risk-based decisions in localized prostate cancer. The decision follows the product’s earlier Breakthrough Device Designation and allows its use as a regulated medical device in qualified pathology laboratories.

#advertisement
AI in Drug Discovery Report 2025

The FDA’s Breakthrough Devices Program supports the development of devices that may offer more effective diagnosis or treatment for serious conditions while maintaining standard safety and performance requirements. ArteraAI Prostate is claimed to be the first AI-powered risk stratification tool for prostate cancer to receive this designation.

Artera’s multimodal artificial intelligence (MMAI) platform combines digitized pathology slides with clinical data to deliver predictive and prognostic insights for personalized cancer care. Built with diverse patient cohorts, including representative African American populations, it preserves tissue by using existing biopsy slides and provides results within days. The system is designed to augment, not replace, physicians, reducing uncertainty in treatment benefit and enabling AI biomarker development across cancer types.

Image credit: ArteraAI in Cancer Therapy

ArteraAI Prostate analyzes digitized prostate biopsy images along with clinical data to estimate long-term outcomes, including 10-year risk of distant metastasis and prostate cancer–specific mortality. It can also assess potential benefit from specific therapies, such as androgen deprivation therapy or abiraterone when combined with radiation. The system is designed for use across all National Comprehensive Cancer Network (NCCN) prostate cancer risk groups, with output available within one to two days of receiving digitized biopsy images and patient data.

 

Image credit: ArteraAI Prostate Test

According to Artera, the platform’s prognostic and predictive models were developed using datasets from thousands of patients and tens of thousands of pathology slides, validated in multiple Phase 3 randomized trials with up to 15 years of follow-up. 

Image credit: ArteraAI Prostate Test

The test is currently commercially available as a laboratory-developed test (LDT) through Artera’s Clinical Laboratory Improvement Amendments (CLIA)–certified, College of American Pathologists (CAP)–accredited lab in Jacksonville, Florida, and is listed in the NCCN Clinical Practice Guidelines for prostate cancer.

Topics: AI & Digital   

Share:   Share in LinkedIn  Share in Bluesky  Share in Reddit  Share in Hacker News  Share in X  Share in Facebook  Send by email
#advertisement
ThermoFisher Scientific: Integrated genetic technologies for cell therapy development
#advertisement
Webinar: AI in Clinical Trials

BiopharmaTrend.com

Where Tech Meets Bio
mail  Newsletter
in  LinkedIn
x  X
gnews  Google News
rss  RSS Feed

About


  • What we do
  • Citations and Press Coverage
  • Terms of Use
  • Privacy Policy
  • Disclaimer

We Offer


  • Premium Content
  • BioTech Scout
  • Interviews
  • Partner Events
  • Case Studies

Opportunities


  • Membership
  • Advertise
  • Submit Company
  • Write for Us
  • Contact Us

© BPT Analytics LTD 2025
We use cookies to personalise content and to analyse our traffic. You consent to our cookies if you continue to use our website. Read more details in our cookies policy.