MedVantage is a searchable FDA market-intelligence platform for medical devices — source-linked device, company, and product-code profiles that roll up into FDA Market Maps you can monitor. Built from public FDA records: clearances, predicates, product codes, recalls, MAUDE, and warning letters.
Search the record. Map the market. Monitor what changes.
The FDA moves that shape your market sit across public systems — 510(k), PMA, De Novo, MAUDE, recalls, warning letters, registration. They don't connect, so no one holds the current picture. MedVantage assembles them into a single FDA Market Map — companies, devices, and signals in one sourced view.
Not a one-time report that's stale the day it's exported — a map built to stay current as new FDA records appear.
Each map is assembled from the same primary FDA records — and sits on top of searchable, source-linked device, company, and product-code profiles you can drill into. Pick the view that matches the job.
Interfaces below are illustrative concepts — not live data.
One map of the FDA record around your devices — so nothing about your own portfolio catches you off guard.
Track a rival's moves as they file — clearances, new entries, and the product codes they're pushing into.
Evaluate a product code or category you're eyeing — who's in it, how they got cleared, and what the risks look like.
MedVantage turns that starting point into a sourced FDA Market Map — connecting the relevant devices, companies, product codes, filings, recalls, MAUDE signals, warning letters, and predicates.
Start from any device, company, product code, or category in the FDA record.
Drill into device, company, and product-code profiles — clearances, predicates, IFUs, recalls, MAUDE, and warning letters, each traceable to its filing.
Roll it up into a Portfolio, Competitor, or Market Entry Map — and monitor new FDA activity as records appear.
Once you have a map, MedVantage is built to monitor its FDA sources and surface new moves for you — a competitor's clearance, a new entrant, a recall, an adverse-event spike, a warning letter. Designed to update as new FDA records appear, so the picture doesn't go stale.
Set the devices, competitors, and categories you care about once. New filings that touch them are designed to surface automatically — no re-running searches, no stale exports.
Each map is assembled from primary, public FDA records — then connected: companies resolved, predicate chains reconstructed, and points linked back to the filing behind it. So a map is something you can defend, not a black box. From each map, users can drill into source-linked device, company, product-code, and filing pages to inspect the underlying FDA record.
Points on a map trace to a public FDA / openFDA filing and link back to it — never third-party estimates standing in for the source.
Applicant, owner-operator, and brand names are reconciled into a single company, so "Northwind Medical Inc." and "Northwind Medical Vascular" count as one.
Predicate chains locked inside 510(k) summary PDFs are extracted and structured into a queryable lineage.
Each source is designed to refresh as new FDA records appear, with each record stamped and linked to its underlying filing.
The FDA records are public — most tools just bury them under logins and forty-filter dashboards. MedVantage gives you the finished profiles and maps instead.
Each map assembles the field around your subject from every FDA source — companies, activity, and history — not one record at a time.
Designed to update as new FDA records appear — no stale exports.
Points on a map link back to the primary FDA record behind it — nothing you can't defend.
Built for emerging and mid-market device companies and the consultants who work with them — anyone who needs to know what the FDA is doing around their market.
Follow 510(k), De Novo, and PMA activity and predicate families to shape and defend your own submissions.
Watch recalls, adverse events, and warning letters across your portfolio and your competitors, with new signals surfaced to your maps.
See where a category is heading — entrants, clearances, competitor moves — to time launches and sharpen positioning.
Size a market and assess a target's regulatory and safety record — figures sourced to a primary filing.
One map the whole team shares — strategy, regulatory, product, and BD working from the same FDA records instead of separate spreadsheets.
Tell us your company, a competitor, product code, or target market. We'll generate a sample platform view showing how MedVantage maps and monitors the FDA landscape.
A sample platform view of your portfolio, competitor set, or target market — built from public FDA records.
Feedback on the map, workflow, and the signals that matter to your team.
Emerging and mid-market device teams and RA consultants. Selective investor/corp-dev use cases welcome.