108 First Street Los Altos, CA 94022, California, United States, 94022
| Device Name | US | UK | CA | AU | EU |
|---|---|---|---|---|---|
| ArteraAI Breast | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ArteraAI Breast Cancer Assay | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ArteraAI Prostate | Registered with US (FDA) | Not registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
| ArteraAI Prostate Biopsy Assay | Not registered with US (FDA) | Registered with UK (MHRA) | Not registered with Canada (Health Canada) | Not registered with AU (TGA) | Not registered with EU (EUDAMED) |
Get alerts on new registrations, recalls, and regulatory changes.