- US-only regulatory requirement
- If procurement requires FDA 510(k) clearance today, Pi™ may not qualify (as of 2026 literature, Pi™ held CE Class IIb marking but not FDA clearance).
- Non-standard imaging protocols / contraindicated populations
- If workflows regularly use endorectal coils, non-PI-RADS protocols, or produce a high proportion of non-diagnostic scans, the product may be inapplicable or require additional governance.
- Low-volume prostate MRI centers
- Low prostate MRI volumes may weaken ROI given integration and validation overheads.
- Buyers needing transparent list pricing
- If published pricing is required for rapid vendor shortlisting, the vendor’s demonstration-led engagement model may be a procurement obstacle.
- Organizations lacking capacity for clinical audit and model monitoring
- Product instructions recommend auditing AI performance after scanner or protocol changes; lack of governance capacity increases deployment risk.
- Current limitations acknowledged by the vendor / formal documentation constraints
- Product instructions contain explicit warnings and contraindications and note that scanner/protocol variability can affect results.
- Examples from documentation:
- The software must not be used for certain patients (recent biopsy, prior treatment/surgery) and for poor-quality scans.
- Documentation cautions about potential bias and recommends governance steps to ensure performance across populations.
- The vendor recommends auditing and re-checking performance after MRI scanner, software, or protocol changes.
- Features on the roadmap (not yet available)
- The vendor has announced ongoing platform updates and potential expansion to additional cancer types; detailed roadmaps and timelines were not published in the materials reviewed.
- Scale limitations
- No public throughput or latency benchmarks for high-volume use cases (cloud vs on-prem performance not publicly benchmarked).
- Security or compliance gaps
- Public-facing security certifications and detailed enterprise security feature documentation are not clearly documented; procurement should request evidence.
- API limitations or integration constraints
- No public developer API documentation was found; integration appears to focus on PACS/RIS imaging workflows rather than open developer APIs.