Cleerly announces coronary CT software updates
Source publication date
Site published
Cleerly announced LABS and PLAQUE coronary CT software updates, planning automatic customer rollout in November. FDA records list July 29 decisions for LABS K260588 and PLAQUE K261210; the announcement does not directly link these numbers.
https://cleerly.com/press/fda-clearance-cleerly-labs
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260588
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261210
Summary
LABS and PLAQUE updates were announced October 30 with a planned November rollout.
Editorial view
Interpretation: a development in AI-assisted cardiac CT analysis.
Evidence and limitations
Rollout completion and patient outcome improvements are unverified. October 30 is not the FDA decision date.