Real-world perspectives on device safety and surveillance
We analyze FDA adverse event data to surface the trends, safety signals, and regulatory intelligence that matter to medical device professionals.
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The HVAD in MAUDE: 49,000 Adverse Event Reports on a Withdrawn Heart Pump
A quantitative retrospective on Medtronic's HeartWare HVAD using five years of public FDA adverse event data, including the failure-mode signature that was visible in MAUDE before the 2021 market withdrawal.
READHow to Search the FDA MAUDE Database (and What It Won't Tell You)
A practical walkthrough of searching FDA MAUDE adverse event reports, the queries that actually work, and the structural gaps that keep raw MAUDE from answering the question most people are actually asking.
READSignal Detection in Post-Market Surveillance Is Broken — Here’s Why
Most medical device signal detection systems fail in practice. This article explains why MDR-based surveillance breaks down—and what a modern, data-driven approach should look like.
READPost-Market Surveillance in the United States: The System We Have vs. the System We Need
Post-market surveillance in the U.S. is more than MDR reporting. This deep dive explains how FDA requirements actually work in practice—and where the system breaks down.
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