Changelog
Product Updates
Follow along as we build the future of post-market surveillance. New features, improvements, and what is coming next.
March 2026
ShippedLaunch
- Automated FDA MAUDE (now AEMS) data ingestion for medical device product codes
- AI-powered adverse event summarization with Claude
- Human-in-the-loop review queue for compliance documentation
- Competitor device monitoring and tracking
- Signal detection dashboards with severity and failure mode analytics
- PSUR-ready trend reports and PDF exports
- Weekly email digests with safety signal summaries
- Slack and webhook notification integrations
- 21 CFR Part 11 compliant audit trails and access controls
- Role-based team management with session timeouts
April 2026
ShippedPost-Launch Improvements
- Custom report templates with branded PDF export
- Enhanced signal detection with spike and severity-trend algorithms
- Bulk event export to CSV for acknowledged reviews
June 2026
ShippedAEMS Transition
- Data ingestion moved to FDA's Adverse Event Monitoring System (AEMS), which replaced MAUDE in May 2026 — no customer action required
- Full MAUDE archive retained and searchable through AEMS
- Automated FDA data-channel monitoring to catch source changes early
On the Roadmap
PlannedFuture Plans
- Multi-source data ingestion (MHRA, BfArM, TGA)
- PubMed clinical literature surveillance
- Custom CAPA workflow integration
- Advanced NLP models for device-specific terminology
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