Regulatory status
One portfolio does not mean one regulatory status.
Each product keeps its own intended-use, validation and access boundary. The most conservative accurate statement is shown when formal positioning remains under review.
| Product | Current public boundary | Access state |
|---|---|---|
| CUPAI | Research use only. Not for clinical diagnosis. | Independent product · account required |
| VeraFusionDx | Public intended-use wording is under formal owner review. Confirm findings with validated clinical methods. | Independent product · public positioning under review |
| PathAIFusion | Research use only. Not an IVD and cannot rule out a fusion. | Local validation · no public product access |
| SmartMTB 2.0 | Informational AI tool. Not a medical device, diagnosis or treatment recommendation. | Independent product · account required |
Owner review required
Marketing copy, product UI, exports, API responses and sales material must use the same approved intended-use wording. This page does not resolve a jurisdiction-specific regulatory decision by itself.