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Cardiovascular Machine Learning-Based Notification Software

FDA product code QXO · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.2380
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2026-06-08 – 2026-06-08

Cardiovascular machine learning-based notification software employs machine learning techniques to suggest the likelihood of a cardiovascular disease or condition for further referral or diagnostic follow-up. The software identifies a single condition based on one or more non-invasive physiological inputs as part of routine medical care. It is intended as the basis for further testing and is not intended to provide diagnostic quality output. It is not intended to identify or detect arrhythmias.

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