MedVantage makes the FDA record searchable. Open source-linked profiles for devices, companies, product codes, and FDA submissions — device descriptions, intended use and indications, IFUs where publicly available, predicate devices, comparison and testing summaries, and regulatory history. Then build FDA Market Maps and monitor what changes.
Research the record. Map the market. Monitor what changes.
Most questions don't start with a map — they start with a device, a company, or a product code. MedVantage resolves your search into source-linked profiles you can actually read, each traceable to the FDA filing it came from.
FDA device description, intended use and indications, IFU where publicly available, predicate devices, comparison and testing summaries, clearance or approval history, and post-market signals.
Every device and submission on the FDA record, the product codes they touch, registered establishments, recalls, warning letters, and full regulatory history — with subsidiaries resolved to one company.
The classification itself — class, regulation, review panel — plus who is cleared in it, how they got cleared, predicate families, clearance timelines, and post-market risk across the code.
The filing itself: decision and dates, pathway, predicates cited, the summary document, and a link straight to the primary FDA record so you can read the original wording.
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.
Sometimes the question is bigger than a single device. A Market Map rolls the same source-linked profiles up into a view of a whole portfolio, competitor, or category. It's one workflow MedVantage supports — not the whole product.
Company figures below are real, from openFDA. Interfaces are illustrative.
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.
Search a device, company, product code, or category. Open the source-linked profiles behind it — descriptions, indications, IFUs, predicates, testing summaries, regulatory history. Roll it into a Market Map when you need the whole field, and monitor it from there.
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.
Every profile, figure, and map point is assembled from primary, public FDA records, then connected: companies resolved, predicate chains reconstructed, and each point linked back to the filing behind it. Where the FDA's own wording matters — indications, device descriptions, IFUs — you read the source text, not a paraphrase of it.
Every point traces to a public FDA / openFDA record and links 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 subsidiaries and legal-entity variants of the same firm count as one.
Predicate chains locked inside 510(k) summary PDFs are extracted and structured into a queryable lineage.
Where the exact FDA wording matters, you get the source text and a link to the original document — not a summary quietly standing in for the record.
The FDA records are public — most tools bury them under logins and forty-filter dashboards, or replace them with summaries you can't check. MedVantage gives you readable, source-linked profiles you can defend in a submission or a board meeting.
Search a device, company, product code, or category and open the profile behind it. No forty-filter dashboard to learn first.
Descriptions, indications, IFUs where public, predicates, comparison and testing summaries — the FDA's own wording, with the document one click away.
Every figure links back to the primary FDA record behind it — nothing you can't defend in a submission or a diligence call.
Built for emerging and mid-market device companies and the consultants who work with them — anyone who needs to know what the FDA says about a device, a company, or a market.
Research predicates, indications, and comparison summaries across 510(k), De Novo, and PMA activity 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 platform the whole team shares — strategy, regulatory, product, and BD working from the same FDA records instead of separate spreadsheets.
Tell us a device, company, product code, or target market. We'll generate a sample view — the profiles, the record behind them, and a Market Map if the question calls for one.
A sample platform view — source-linked device, company, or product-code profiles for your subject, 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.