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Cardiac Amyloidosis Machine Learning-Based Notification Software

FDA product code SHP · 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
2026-04-07 – 2026-04-07

Cardiac Amyloidosis machine learning-based notification software employs machine learning techniques to suggest the likelihood of cardiac amyloidosis for further referral or diagnostic follow-up.

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