Compliance & Certifications
Every Capnova solution meets rigorous international standards for safety, efficacy, data privacy, and interoperability.
FDA & CE Cleared
All AI diagnostic platforms — Rayscape AI, VUNO Fundus AI, and RetinaLyze AI — are FDA cleared and CE marked for clinical use.
Infection Control Standards
UVX Far-UVC technology is validated against WHO, CDC, and ASHRAE standards for air and surface disinfection in healthcare environments.
Data Privacy & Security
All systems are HIPAA-aligned and support HL7/FHIR interoperability standards for seamless health data exchange.
International Standards
Modular infrastructure and equipment comply with IEC, ISO, and applicable local construction and clinical safety standards.