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Intended Use

Cleerly Labs is a web-based software application for trained medical professionals to view and analyze cardiac CT data for presence and extent of coronary plaques (atherosclerosis) and stenosis in patients undergoing CCTA to evaluate CAD or suspected CAD. It post processes CT images from any CT scanner and provides tools for coronary artery measurement and visualization.

Technology

Cleerly Labs uses machine learning and rule-based calculations on backend software to identify high quality images, segment and label coronary arteries, and lumen and vessel walls using deep learning. It provides 2D and 3D images for user review and editing, supporting measurement outputs based on segmentation and user input. The software generates an interactive coronary report summarizing analysis findings to aid clinical evaluation.

Performance

Verification and validation testing in accordance with recognized standards demonstrated that the device meets predefined specifications with usability tests and cybersecurity penetration tests ensuring clinical acceptability and data security. Performance compared to expert readers showed strong correlation for lumen, vessel, and plaque volumes. Non-clinical testing confirmed safety and effectiveness; no clinical testing was conducted due to sufficient non-clinical evidence.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    8/11/2020

    1 month
  • 2

    FDA Approval

    10/2/2020

Other devices from Cleerly, Inc.

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