Monitoring
What changed — and whether it can move a shortlist
Snapshot snap_8a8a4c9bb810aee3 · cutoff 2026-08-27T04:05Z. 0 of 2 events in this filter set may change a shortlist.
- 2026-02-26FDA grants six new 510(k) indications for qXR-Detect chest X-ray CADe (26 total cleared indications)New but not decision-changing · Imaging & Diagnostic AI · Historical
Provenance
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?id=K200921
- 2025-09-22New but not decision-changing · Imaging & Diagnostic AI · Historical
Provenance
https://ir.heartflow.com/news-releases/news-release-details/heartflow-announces-fda-510k-clearance-and-launch-next