HeartFlow Analysis
HeartFlow, Inc.HeartFlow Analysis is a software medical device that uses AI to analyze coronary CT angiography images. It provides detailed anatomical and physiological information about the coronary arteries, helping clinicians assess the risk and severity of coronary artery disease, aiding in treatment planning and diagnosis.
Intended Use
The HeartFlow Analysis is an AI-based medical device software for the clinical quantitative and qualitative analysis of previously acquired Computed Tomography DICOM data for patients with suspected coronary artery disease. It provides anatomic data, plaque identification and characterization, as well as calculations of FFRCT, a coronary physiological simulation, computed from simulated pressure, velocity and blood flow information obtained from a 3D computer model generated from static coronary CT images. It supports risk assessment and functional evaluation of coronary artery disease.
Technology
HeartFlow Analysis uses AI and machine learning algorithms trained on large volumes of CT data to extract anatomical data and simulate coronary physiology (FFRCT) from coronary CT angiography images. It produces graphical and textual output for clinician interpretation and is designed as a non-invasive, DICOM-compatible software package accessed via internet connectivity.
Performance
The device underwent extensive validation including stress testing, repeatability testing, and clinical data evaluation through previous clinical trials to ensure its safety and effectiveness. Results from current and prior testing demonstrate that the device performs as well as legally marketed predicate devices and is acceptable for use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/10/2021
10 months - 2
FDA Approval
10/14/2022
Other devices from HeartFlow, Inc.
- HeartFlow Analysis2021 • 510K
- HeartFlow FFRct Analysis2019 • 510K
- FFRct2018 • 510K
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