Heartvue.Proton
Heartvue.ai, Inc.Heartvue.Proton is a software tool that uses artificial intelligence to automatically measure structures in heart MRI scans. It helps doctors analyze the heart and blood vessels more efficiently and accurately, supporting decision-making for patients with cardiovascular disease.
Intended Use
Heartvue.Proton is indicated for use in clinical settings where quantified results are needed to support the visualization and analysis of MR images of the heart and blood vessels for use on individual patients with cardiovascular disease. The results are to support, but not solely determine, clinical diagnosis and are only for use by responsible clinicians.
Technology
Heartvue.Proton is a web-based, software-only device utilizing machine learning algorithms organized into pipelines for semi-automated segmentation, measurement, and analysis of cardiac MR images. It generates 48 quantitative cardiac measurements, all of which can be edited by clinicians, and introduces workflow enhancements such as automated grading based on reference ranges.
Performance
The device underwent software verification/validation testing, nonclinical (bench) performance testing comparing automated ML-based measurements to manual measurements, and a clinical evaluation comparing automated outputs to expert consensus. All primary endpoints and segmentation criteria were met, with the device reducing measurement time by nearly fivefold compared to manual methods.
Predicate Devices
No predicate devices specified
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