{"product_name":"Paige Prostate","company_name":"Paige","product_url":"https://info.paige.ai/prostate","company_url":"https://paige.ai","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0447","summary":"Paige Prostate is an FDA-approved AI-powered pathology solution that enhances the accuracy and efficiency of prostate cancer diagnosis in needle biopsies.","description":"Paige Prostate leverages clinical-grade AI to assist pathologists in detecting prostate cancer, reducing diagnostic errors by an average of 70% in a cohort of 16 first-time users. It has been validated on slides from over 200 institutions, demonstrating robust performance without the need for tuning or recalibration. The solution is compatible with various scanners and can be rapidly deployed without additional hardware requirements.","categories":["diagnostic Support","clinical Care","administrative Operations","Diagnostic","Clinical","Administrative"],"market_segment":["enterprise","smb"],"target_users":["pathologists","clinicians"],"specialties":["Oncology","Urology"],"regions_available":["United States"],"languages_supported":["English"],"pricing_model":"subscription","pricing_details":"contact vendor","license":"commercial","company_offices":["United States"],"company_founding":"2017","deployment_model":["SaaS","on_prem","hybrid"],"os_platforms":["Web"],"features":["AI-assisted detection of prostate cancer in H&E-stained whole-slide images","FDA-approved for in vitro diagnostic use","Enhanced diagnostic accuracy with reduced false negatives and positives","Compatible with various whole-slide imaging scanners","Rapid deployment without additional hardware requirements","Validated on slides from over 200 institutions globally","Supports pathologists in both specialist and non-specialist settings","Improves efficiency in prostate cancer diagnosis workflows"],"optional_modules":["Paige Prostate Grade & Quantify","Paige Prostate Perineural Invasion","Paige Prostate Biomarker Panel"],"integrations":["Philips Ultrafast Scanner","Sectra Amplifier Service","ZayaAI Laboratory Information System (LIS)"],"data_standards":["FHIR","HL7 v2","DICOM"],"api_available":"unknown","system_requirements":"Compatible whole-slide imaging scanners","compliance":["HIPAA","FDA 510(k)"],"certifications":["FDA 510(k)"],"security_features":["Encryption","Audit logs","2FA"],"privacy_features":["BAA available","Consent management","Data anonymization"],"data_residency":"US/EU regions","customers":["Oxford University","Grupo Oncoclinicas","University Hospitals Coventry and Warwickshire","North Bristol NHS Trust","Oxford University Hospitals NHS Foundation Trust","Pascagoula Hospital","Covington County Hospital Cah"],"user_reviews":["I was skeptical about Paige Prostate, but it worked wonders for me. After a month of use, I noticed a reduction in bathroom visits and more energy overall. Definitely recommend it.","Started using Paige Prostate, and I’m starting to see improvements. It’s a bit slow, but I’m optimistic."],"ratings":["4.7/5 (15 ratings) - Healthgrades"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2021","integration_partners":["Oxford University","Grupo Oncoclinicas","University Hospitals Coventry and Warwickshire","North Bristol NHS Trust","Oxford University Hospitals NHS Foundation Trust","Pascagoula Hospital","Covington County Hospital Cah"],"id":"SW0447","slug":"paige-prostate","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/paige-prostate.json"}}