Editions / Life sciences

DevicePath

Life sciences  Software tool
The job to be done

“Map predicate landscape and safety-signal risk before I file.”

Regulatory strategy for a device clearance starts with the predicate landscape — and the safety history connected to it. DevicePath maps public clearance lineages and links them to recall and adverse-event histories, rate-normalized so genuine signal stands out from reporting volume, with post-market monitoring bundled in.

How it works — process view
Ingestpublic device recordsLinkpredicate lineagesNormalizeevent ratesMaprisk atlasReviewanalyst gatePredicate atlasIllustrative process view. Panel composition, tagging logic, and scoring methods are proprietary and ship under license.
Why this matters
  • Predicate choice shapes clearance timeline and challenge risk — the lineage map is the first strategic document
  • Raw adverse-event counts mislead; rate-normalized signals separate real risk from reporting volume
  • Post-market surveillance on the same atlas means early warning arrives in context, not as a raw feed
Key features

Predicate lineage maps across public clearance pathways

Recall and adverse-event histories cross-linked to each lineage

Rate-normalized safety signals adjusted for reporting volume

Post-market monitoring with interim safety alerts

Scoped views by device category and regulatory pathway

The quality process behind it
  • Named primary source and capture date on every figure — if a number can’t carry its lineage, it doesn’t ship
  • Append-only history: prior observations are preserved, never overwritten, so point-in-time claims hold up
  • Enforced refresh cadence with continuous freshness monitoring against an objective coverage yardstick
  • Analyst review gate before every release — auto-assembled drafts never reach a subscriber unreviewed
Why this outruns AI-alone answers
  • Predicate relationships are multi-hop and buried in decades of public filings — mapping them takes curation, not retrieval
  • Raw event counts are the classic AI trap; normalization requires denominators that must be assembled, not prompted
  • A filing strategy carries regulatory consequence — it needs figure-level lineage and an analyst gate
By the numbers
510(k) + PMApublic clearance pathways mapped into predicate lineages
Rate-normalizedsafety signals adjusted for reporting volume, not raw counts
Quarterlyrisk-atlas refresh with interim safety alerts
100%of figures traceable to a named public source and capture date
How ordering works

1. Request access

Tell us your organization, role, and intended use — most requests get a response within one business day.

2. Qualification review

A brief review confirms scope, licensing lane, and any buyer-type or geography restrictions. We tell you plainly if yours is restricted.

3. Order & payment

Approved orders receive a secure Stripe checkout link — card, ACH debit, Apple Pay — or a countersignable quote. Enterprise orders run on invoice.

4. Entitlement provisioned

Access and delivery entitlements are provisioned the same day payment clears, with license terms attached to the order.

Annual subscription scoped by device category; quarterly atlas refresh with interim safety alerts.

Request access Read the methodology