Augmented Reality Surgical Navigation

Regulatory & Compliance

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VisAR is currently FDA-cleared for intraoperative stereotactic spinal surgical guidance, for both minimally invasive (MISS) and open surgery. Additional FDA submissions are pending.

VisAR meets the following regulatory standards:

  • DICOM
  • HL7
  • HIPAA and HITECH
  • ISO 13485 (for over 10 years)
  • MDSAP
  • CE

Compliance

  • FDA (USA) 510(k) approval - OpenSight (pre-operative), VisAR (spinal)
  • CE/MDR (Europe) - OpenSight (pre-operative)
  • Indonesia (MOH Certificate) - VisAR (spinal) - Stereotaxic Instrument System

HIPAA Compliance

Novarad Corporation is dedicated to helping our customers ensure the confidentiality, integrity, and availability of their electronic health information. Novarad makes every effort to conduct our business in compliance with the privacy and security standards set forth in the Health Insurance Portability and Accountability (HIPAA) Act of 1996, the Health Information Technology for Economic and Clinical Health (HITECH) ACT of 2009, and all other applicable information security standards as required by law. 

Certificates

Learn more about VisAR