Founded by two doctors, Smileyscope develops medical-grade virtual-reality digital therapeutics that help clinicians reduce pain and anxiety during healthcare procedures. Its purpose-built headset and evidence-based software have supported more than 400,000 procedures across four continents, from children’s hospitals to rural clinics, and are designed to work without Wi-Fi or Bluetooth in everyday clinical settings. The company’s technology is FDA Class II cleared, TGA registered and CE marked.
FDA Class II Cleared
TGA Class 1 Registered
Registration
CE Marked
EN ISO 14971:2012
Compliance program
EN 62366:2008
Compliance program
EN ISO 10993-1
Compliance program
CE
Quality certification