What's actually shipped, and what's next.
We don't market a capability before the code ships. This page is the honest split: what renders in every report today, what's in active development, and what's scoped on the roadmap. It updates as capabilities graduate.
- Ranked predicate candidates with full FDA Best Practices scorecards
- 8-dimension substantial-equivalence comparison (eSTAR-aligned), including contraindications
- Predicate lineage — citation chains three levels deep
- Safety surveillance — MAUDE adverse events + recall classification
- Regulatory pathway decision engine — Traditional / Special / Abbreviated 510(k), De Novo, Breakthrough, PMA — with a device-risk read
- De Novo & Breakthrough eligibility assessment
- Pre-Submission Question Packet — draft Q-Sub questions, similarities/differences scaffold, and testing approach
- IDE determination when clinical data is likely needed
- Device-specific FDA guidance matched to your specialty panel
- AI/ML Signature Intelligence — PCCP precedents, algorithm-change patterns, foundation-model disclosures
- Dual-classification (multi-product-code) handling + product-code review
- eSTAR section mapping + drafted 510(k) Summary narrative
- Score Composition appendix + citation-freshness stamping
- PDF and editable Word (.docx) export
De Novo pathway analytics
Corpus-backed De Novo precedents. The eligibility assessment already ships in every report today; the precedent library that surfaces specific matched De Novo grants is being populated before it goes live.
Reimbursement Pathway Analyzer
The clearance-to-coverage layer: HCPCS / ICD-10 candidates, Medicare payment lines, and NCD coverage from clearance forward. In private beta with design partners.
Consultant white-label & Team subscriptions
Editable .docx delivery, portfolio dashboard, and monitoring, built for consultancies and in-house RA teams. In development with select firms.
- Cybersecurity Package Generator
- Pre-Submission Strategist
- Letter-to-File Engine
- Competitor Clearance Monitor
- MAUDE Safety Surveillance
- US → EU Crosswalk
- Launch Readiness Playbook
No marketing claim on this site runs ahead of shipped code. If something isn't yet live, it's labeled in-development or roadmap here — never implied as available elsewhere.