HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4
Bracco Diagnostics Inc.HeartSee Cardiac P.E.T. Processing Software is a tool that helps trained clinicians analyze heart PET images to quantify blood flow and heart function. It provides detailed maps and measurements that assist in diagnosing coronary artery disease by measuring myocardial perfusion and coronary flow reserve. This enables better clinical interpretation and patient management based on quantitative PET imaging data.
Intended Use
HeartSee software for cardiac positron emission tomography (PET) is indicated for determining regional and global absolute rest and stress myocardial perfusion in cc/min/g, Coronary Flow Reserve and their combination into the Coronary Flow Capacity (CFC) Map in patients with suspected or known coronary artery disease (CAD) in order to assist clinical interpretation of PET perfusion images and quantification of their severity.
Technology
HeartSee imports cardiac PET images in DICOM format, reorients them to cardiac axes, produces standard tomographic and topographic displays and quantifies myocardial perfusion in cc/min/g, Coronary Flow Reserve as the stress/rest perfusion ratio, and Coronary Flow Capacity combining both. It also calculates left ventricular ejection fraction by PET-CT and provides output data archiving. The software runs on Windows OS with cybersecurity enhancements.
Performance
Performance testing included nonclinical system and cybersecurity testing to verify software functionality and safety. No clinical testing was performed since device design and function are essentially identical to the predicate device.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/18/2024
2 months - 2
FDA Approval
3/3/2025
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