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# Coronary Artery Disease Risk Indicators in Class 2
- URL: https://www.fdaweb.com/coronary-artery-disease-risk-indicators-in-class-2/
- Published: 2022-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:47:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5151942

*Federal Register* notice: FDA is classifying coronary artery disease risk indicators using acoustic heart signals into Class 2 (special controls). The action is based on an Acarix’s request for de novo classification of its CADScor System. The agency has identified it as a device that records heart sounds including murmurs and vibrations to calculate a patient-specific risk of presence of coronary artery disease, as an aid in cardiac analysis and diagnosis. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-06-01/pdf/2022-11699.pdf?ref=fdaweb.com).