Spot adverse event spikes weeks before they hit your desk
Thousands of MAUDE reports land every week. Claripulse watches all of them — and alerts you only when the statistics say something is wrong.
~1M
Reports Analyzed
10K+
Devices Monitored
Weekly
Updates
200+
Active Signals
MAUDE reporting is growing. Manual review isn't scaling.
10,000+ adverse event reports filed every month across cardiology devices alone
Whether you’re filing MDRs or evaluating device risk, the signal is buried in noise
By the time a trend is obvious, you’re already in reactive mode
Claripulse replaces the spreadsheet with statistical surveillance.
From raw data to safety intelligence
Three automated steps transform FDA adverse event reports into actionable signals — no manual review required.
Ingest
Every week, the latest MAUDE reports are automatically pulled, normalized, and matched to your device catalog. No downloads, no data wrangling.
Detect
Five statistical models scan for anomalies — sudden spikes, creeping trends, new failure modes, and devices reporting above their peer group.
Alert
Only statistically significant signals reach your dashboard — ranked by severity, with full device context and historical baselines. No noise.
Never miss a safety signal again
Claripulse runs five detection algorithms every week — so emerging safety signals surface in your dashboard, not buried in a backlog of unread reports.
- Adaptive thresholds that account for device maturity — new devices aren’t held to legacy baselines
- Severity-ranked alerts so your team focuses on what matters most
- Zero-noise tuning — only statistically significant anomalies surface
Active Signals
ICD Lead — Spike detected
Critical12 reports this week vs. 3 avg
Drug-eluting stent — Trend up
WarningRising 18% over 90 days
EP catheter — New problem code
InfoFirst occurrence of code 2993
Complete device intelligence in one place
Stop cross-referencing MAUDE downloads with GUDID lookups and 510(k) databases. Every device gets a unified profile with report history, event breakdowns, and regulatory context.
- Automatic GUDID matching across 4,200+ devices — no manual catalog maintenance
- Manufacturer normalization resolves naming variants automatically
- PMA and 510(k) clearance data cross-referenced in context
Device Profile
Cardiac Resynchronization Therapy Defibrillator
Product code: MKJ | Medtronic
1,847
Total Reports
+12%
30-day Change
3/18
Peer Rank
Seven years of trends, one click away
See how any device’s adverse event profile has evolved over seven years. Compare it against its peer group to know instantly if a trend is device-specific or category-wide.
- Interactive trend charts spanning 2019 to present
- Peer-group benchmarking shows outliers at a glance
- 30-day and 90-day momentum indicators flag emerging issues early
Report Trend
90-day change
12%
Weekly avg
14.3
Powered by FDA data. Driven by statistics.
Three authoritative data sources, five detection algorithms, and a dashboard built for the people who need it most.
FDA MAUDE
Complete adverse event and malfunction reports — automatically ingested and normalized every week.
GUDID Registry
FDA’s Global Unique Device Identification database — used to match and enrich every device profile.
openFDA API
PMA approvals, 510(k) clearances, and regulatory context — cross-referenced with every signal.
Regulatory Affairs
“Reacting to FDA inquiries after the fact, manually piecing together MAUDE data.”
Surface emerging signals weeks before enforcement thresholds are reached.
Quality & Compliance
“CAPA decisions rely on anecdotal reports and gut instinct.”
Ground every decision in maturity-adjusted baselines and peer data.
Clinical Engineering
“No systematic way to compare safety across manufacturers at scale.”
Device portfolio ranked by signal severity, with vendor-level comparisons.
Post-Market Surveillance
“Manually reviewing MAUDE database dumps is unsustainable.”
Automated statistical surveillance — only see what’s significant.
Get signal alerts before everyone else
Join the early access list for weekly signal digests covering cardiology devices — free during beta.