InVision Precision Cardiac Amyloid
InVision Medical Technology CorporationInVision Precision Cardiac Amyloid is a software tool that uses machine learning to analyze echocardiogram videos and identify signs of cardiac amyloidosis in patients aged 65 and older. It integrates with existing hospital imaging systems and helps physicians screen patients by providing decision support alerts to guide referrals for further confirmatory tests.
Intended Use
InVision Precision Cardiac Amyloid is intended to provide adjunctive information on a patient’s cardiovascular condition (diagnostic aid for cardiac amyloidosis).
Technology
The device is a Software as a Medical Device (SaMD) that uses a machine learning algorithm to analyze echocardiogram videos (ultrasound images) acquired during routine cardiovascular assessment. It outputs a report suggesting the presence or absence of cardiac amyloidosis. The software integrates with the institution's PACS system and operates on hosted platforms. It complies with IEC 62304 software standards and ISO 14971 risk management. The AI model was trained and validated on echocardiogram data from multiple US sites.
Performance
The device underwent technical validation including numerical stability and regression testing, and clinical validation on 1221 echocardiogram studies representative of the intended population. It achieved 60.7% sensitivity and 99.0% specificity in detecting cardiac amyloidosis, with performance consistent across subgroups such as age, gender, race, and imaging device manufacturer. Human factors testing confirmed safe and effective use by clinicians. Cybersecurity testing showed no vulnerabilities.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/17/2024
5 months - 2
FDA Approval
5/21/2025
Other devices from InVision Medical Technology Corporation
- InVision Precision LVEF (LVEF)2024 • 510K
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