ROADMAP · SHIPPED VS COMING
What's shipped. 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.
SHIPPED — live in every report today
- Ranked predicate candidates with full FDA Best Practices scorecards
- Predicate quality gates — clinical-function match + relevance floor, so "no adequate predicate" is a finding you can trust
- 8-dimension substantial-equivalence comparison (eSTAR-aligned), including contraindications
- Predicate lineage — citation chains three levels deep
- Readiness grade + FDA decision-time benchmark for comparable submissions
- Safety surveillance — code-level MAUDE signal + per-candidate deep dive with FDA links, plus 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 + matched De Novo grant precedents, labeled by match strength
- PMA-only guardrail + Adjacent Approvals landscape (nearest PMA and De Novo approvals when no 510(k) predicate can exist)
- Product-code review — confirmed/disputed with high-fit alternates — plus a code-strategy call (one code, a pair, or no clean fit) at the classification step
- Software taxonomy — SaMD vs SiMD, AI subtype, locked vs adaptive
- Input Coach — on-demand critique of your device description + Intended Use before the analysis spends a credit
- 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 export in every report + editable Word (.docx) delivery via Partner plans
IN DEVELOPMENT — partially built or in private beta
Reimbursement Pathway Analyzer
The clearance-to-coverage layer, built end to end: CPT/HCPCS + ICD-10 candidates, Medicare pricing across all three fee schedules (PFS, OPPS, DMEPOS), NCD/LCD + commercial coverage outlook, novel-technology pathways, evidence-gap analysis, and an A–F readiness grade. In private beta with design partners.
Partner plan surfaces
Portfolio dashboard, shared team workspace, and white-label co-branding for consultancies and in-house RA teams. Editable .docx export already ships today — email us to set up a Partner plan.
ON THE ROADMAP — scoped, not yet started
- Cybersecurity Package Generator
- Pre-Submission Strategist
- Letter-to-File Engine
- Competitor Clearance Monitor
- Continuous post-clearance MAUDE monitoring
- US → EU Crosswalk
- Launch Readiness Playbook