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# FDA De Novo OK for CaRi-Heart Coronary Inflammation Technology
- URL: https://www.fdaweb.com/fda-de-novo-ok-for-cari-heart-coronary-inflammation-technology/
- Published: 2026-07-29T12:00:00.000Z
- Updated: 2026-09-14T13:43:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161545

FDA has granted *de novo* authorization for Caristo Diagnostics’ CaRi-Heart, described by the company as the first and only technology authorized in the U.S. to quantify coronary inflammation from routine coronary CT angiography. A company [statement](https://www.prnewswire.com/news-releases/caristo-diagnostics-cari-heart-coronary-inflammation-technology-authorized-by-us-fda-302837657.html?ref=fdaweb.com) says it will begin the CaRi-Heart commercial launch this quarter and expand through the end of the year.

The company says CaRi-Heart’s flagship technology used advanced artificial intelligence to detect inflammation-related changes in the fat surrounding the coronary arteries and quantify them in a fat attenuation index score. The analysis is said to also generate a personalized estimate of a patient’s risk of cardiovascular mortality over 10 years.