Dive Brief:

• Caristo Diagnostics has received de novo authorization for an AI tool that quantifies coronary inflammation from routine imaging scans, the company said last week.
• The Food and Drug Administration authorization covers a device, CaRi-Heart, that uses coronary computed tomography angiography to estimate a patient’s risk of cardiovascular mortality over 10 years.
• Research suggests the tool could help physicians stratify risk among patients who present with chest pain but are free from obstructive coronary artery disease.

Dive Insight:

CCTA images the heart and coronary arteries to detect narrowed or blocked vessels. Patients diagnosed with obstructive CAD undergo treatment to clear blockages. People with clear arteries can still suffer heart attacks and other major adverse cardiac events, or MACE. Traditional tools are unable to identify high-risk patients without obstructive CAD. 

A U.K. study of Caristo’s technology found patients without obstructive CAD accounted for two-thirds of MACE and total cardiac deaths. The study enrolled more than 40,000 people undergoing CCTA at eight U.K. hospitals and tracked them for a median of 2.7 years. 

Technology from Caristo, a University of Oxford spinout, successfully differentiated patients at very high risk of cardiac mortality and MACE from people at low or medium risk. The tool combined a score based on inflammation-induced radiological changes, plaque burden and the patient’s risk factors to assign individuals to one of three risk categories. 

The device is the first technology authorized in the U.S. to quantify coronary inflammation from routine CCTA, Caristo said. The company plans to launch the product commercially in the U.S. this quarter and expand the rollout in the fourth quarter, leveraging reimbursement codes that took effect in January. 

Caristo has built out its team in preparation for the launch. Stephen Deitsch joined Caristo as CEO in April, bringing experience gained as CFO of OrganOx. Terumo bought OrganOx for $1.5 billion during Deitsch’s time as CFO.

Last month, Caristo revealed the appointments of David Vort as chief commercial officer and Chris Louk as CFO. Vort previously worked as chief commercial officer at Cytovale and iRhythm Technologies. At Caristo, Vort will oversee commercialization of CaRi-Heart and CaRi-Plaque, which the FDA cleared last year for coronary plaque and stenosis quantification.