FDA filings monitored daily
Every FDA signal,
filtered to what moves your pipeline.
A weekly regulatory intelligence brief focused on pharmaceuticals and medical devices, for RA/QA and business development teams — approvals, warning letters, and recalls, read down to the filing and translated into five markets.
05
markets covered
52
briefs per year
7,281
filings, a typical week
New molecular entities4
Efficacy supplements5
510(k) clearances83
PMA approvals, original2
Drug recalls11
Warning letters1
openFDA · Federal Registerevery brief, updated weekly
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Inside a typical week’s brief
An excerpt from a recent issue’s 510(k) table.
510(k) clearances, ranked by review time
Every device cleared that week, sortable by product code, sponsor, and days-to-decision — cross-referenced against your watchlist companies.
EXCERPT — INDIVIDUAL EDITION
510(k) — Aug 6–12, 2026
sorted by review time
MBI
AIR+ Meniscal Repair Device — Stryker Endoscopy
20d
MOS
dS Breast Coil — Philips Medical Systems
21d
PPN
Shockwave E8 IVL Catheter — Shockwave Medical
28d
ONN
Lantern Knee Navigation Unit — Orthalign, Inc.
29d
JWH
ACTIFY™ Total Knee System — Globus Medical
30d
CADENCE
Weekly, not real-time noise
One brief every week, timed to FDA’s own posting cycle — built for a
Monday-morning read, not a live feed you have to babysit.
SEATS
Individual and corporate plans
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Read the top of each week’s brief at no cost. Full detail and the
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TROY INTELLIGENCE — REGULATORY & MARKET INTELLIGENCE
SOURCES: FDA / FEDERAL REGISTER / OPENFDA