Home / Intelligence / Blog / AI-Based Software Paige Prostate is Granted FDA Approval Through the De Novo Regulatory Pathway
Published September 27, 2021
Paige Prostate is the first artificial intelligence (AI)-based software designed to identify areas of concern (i.e., high likelihood of containing cancer) on a prostate biopsy image so they can be flagged for further review by a pathologist. The program is intended to be used as an adjunct tool to the review of digital scanner slide images from prostate biopsies.
The program was reviewed through the De Novo pathway, a regulatory pathway for low-to-moderate risk novel devices. The FDA authorization is based on clinical trial data which suggests improved detection of cancer on slide images by an average of 7.3% with Paige Prostate vs. unassisted examination by pathologists. The program also reduced the number of false-negatives by 70% and false-positives by 24%. This FDA authorization follows Paige AI receiving a CE mark for both its prostate software and its breast cancer product for use in the EU last year.
Paige’s co-founder and chief medical officer, David Klimstra, notes that Paige’s landmark FDA-approval and EU access “marks the beginning of a new era in the use of computer-assisted diagnostics for pathology.”
Written by Crystal Zhao and Kate Watkins
Related Intelligence
Blog
AI-driven Advancements in Life Sciences
The momentum behind AI-driven advancements in life sciences has never been stronger, and this trend was spotlighted in Everest Group’s new 2025 PEAK Matrix® report, “Life Sciences AI and Analytics Services for Commercial PEAK Matrix® Assessment 2025.” Trinity Life Sciences is honored to be recognized as a Leader in this comprehensive assessment, a distinction rooted […]
Read More
Webinars
Making Segmentation Real with AI Webinar Series
September 30, 2025 | 1:00 PM ET & October 16, 2025 | 12:00 PM ET
“This is the gold standard approach to segmentation.” —Trinity Life Sciences’ client and repeat Weave user Life sciences companies often struggle with fragmented data, complex segmentation solutions, and difficulty translating analytical segments into actionable engagement strategies. Join us for a two-part webinar series showcasing two of Trinity’s AI-enabled solutions, Real Insights Weave and Auras, designed to […]
Sign Up Now
Webinars
Unlocking Medical Impact with AI
September 18, 2025 | 1:00 – 1:45 PM ET
Medical Affairs teams are under growing pressure to deliver faster insights, smarter engagement, and measurable value—yet many are limited by manual processes, fragmented data, and time-intensive workflows. Join us for the next webinar in our “AI Innovations in Life Sciences” series, where Trinity experts will show how it is possible with AI to unlock deeper, novel insights, power efficient workflows, and drive greater impact in the Medical Affairs field and headquarters functions.
Sign Up Now