Caristo Wins FDA Clearance for AI Solution to Prevent Heart Attacks
Caristo Diagnostics, focused on transforming the diagnosis and treatment of cardiovascular disease, has announced that its CaRi-Plaque technology has received 510(k) clearance from the FDA. CaRi-Plaque is an AI-powered image analysis tool designed to support the diagnosis of coronary artery disease (CAD).
Coronary inflammation leads to plaque buildup in the arteries, often without symptoms, until it causes heart attacks or strokes. Fatty plaque deposits weaken the artery walls over time, and while medications like statins and blood pressure drugs can slow this process, many heart attacks occur i...