Biograph and Caristo Diagnostics announced the launch of what they describe as the first U.S. clinical study to explore AI-powered detection of coronary artery inflammation in asymptomatic patients, the companies said.
The trial, open to Biograph’s high-tier “Black Tier” members who meet clinical eligibility, will use Caristo’s CaRi-Heart and CaRi-Plaque technologies on cardiac CT scans to assess whether combining inflammation and plaque data improves early heart disease detection.
Initially, 100 participants will be enrolled starting in October. Prospective subjects will undergo a health history review and consultation before imaging to confirm study suitability. The companies said the trial aims to validate previous findings suggesting CaRi-Heart can identify patients at elevated risk up to a decade in advance, even when no plaque is visible.
CaRi-Heart is already used in Europe, and this marks its first research application in a U.S. asymptomatic population, according to the company. Biograph expects the study to further its preventive healthcare mission, while Caristo positions the trial as a step toward broader adoption of its AI diagnostic tools in the U.S.
