FDA Authorizes Caristo's AI Tool for Cardiovascular Risk Assessment

Caristo Diagnostics has received FDA de novo authorization for CaRi-Heart, an AI tool that quantifies coronary inflammation from routine CCTA scans to estimate 10-year cardiovascular mortality risk. The technology addresses a critical gap, as a U.K. study of 40,000 patients showed that those without obstructive coronary artery disease account for two-thirds of cardiac deaths. Caristo plans to launch CaRi-Heart commercially in the U.S. in the third quarter of 2026, led by newly appointed CEO Stephen Deitsch.

CaRi-Heart FDA de novo authorization

• ▪Caristo Diagnostics received FDA de novo authorization for its CaRi-Heart AI tool to quantify coronary inflammation from routine imaging scans in July 2026.
• ▪The FDA de novo authorization covers CaRi-Heart's use of coronary computed tomography angiography (CCTA) to estimate a patient's 10-year risk of cardiovascular mortality.

Coronary inflammation AI technology

• ▪The CaRi-Heart tool combines a score based on inflammation-induced radiological changes, plaque burden, and patient risk factors to categorize cardiovascular mortality risk.
• ▪CaRi-Heart is the first technology authorized in the United States to quantify coronary inflammation from routine coronary computed tomography angiography (CCTA) scans.

Non-obstructive CAD risk stratification

• ▪Traditional diagnostic tools are unable to identify high-risk cardiovascular patients who do not have obstructive coronary artery disease (CAD).
• ▪CaRi-Heart is designed to help physicians stratify cardiovascular risk among patients presenting with chest pain who do not have obstructive coronary artery disease (CAD).

U.K. clinical study results

• ▪The United Kingdom clinical study tracked patients for a median of 2.7 years and demonstrated that Caristo Diagnostics' technology successfully differentiated high-risk patients from low- or medium-risk patients.
• ▪A United Kingdom clinical study of more than 40,000 patients undergoing CCTA at eight hospitals found that patients without obstructive coronary artery disease (CAD) accounted for two-thirds of major adverse cardiac events (MACE) and total cardiac deaths.

Caristo commercial launch preparation

• ▪Caristo Diagnostics plans to commercially launch CaRi-Heart in the United States in the third quarter of 2026, with plans to expand the rollout in the fourth quarter of 2026.
• ▪The commercial rollout of CaRi-Heart in the United States will leverage reimbursement codes that took effect in January 2026.

Executive leadership appointments

• ▪Stephen Deitsch joined Caristo Diagnostics as chief executive officer in April 2026, having previously served as chief financial officer of OrganOx.
• ▪Caristo Diagnostics appointed David Vort as chief commercial officer and Chris Louk as chief financial officer in July 2026.
• ▪David Vort will oversee the commercialization of CaRi-Heart and CaRi-Plaque, the latter of which received FDA clearance in 2025 for coronary plaque and stenosis quantification.

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