Elucid, a Boston-based medical technology company, has received 510(k) clearance from the U.S. Food and Drug Administration for its PlaqueIQ™ software, a tool designed to help doctors diagnose cardiovascular disease by providing detailed insights into arterial plaque. PlaqueIQ is the first non-invasive software cleared by the FDA that can accurately measure and classify plaque inside arteries based on histology, the gold standard for understanding plaque composition.
Plaque plays a major role in heart attacks and strokes, which are the leading causes of death globally. While doctors often evaluate a person’s age, lifestyle, and other risk factors, the biggest predictor of future heart problems is the amount and type of plaque in a patient’s arteries. Yet, nearly half of Americans between 45 and 84 may have plaque build-up (atherosclerosis) without even knowing it.
PlaqueIQ aims to provide doctors with a clearer picture of what’s happening inside a patient’s arteries by analyzing non-invasive coronary CT scans. It helps doctors identify dangerous types of plaque, such as lipid-rich necrotic cores, which can indicate a higher risk of heart attack or stroke. This detailed information can help guide decisions about how to treat patients—whether through medication or more intensive procedures—before they experience major health issues.
Dr. Amir Ahmadi, a cardiologist at Mount Sinai in New York, explained, “Instead of just estimating someone’s risk, PlaqueIQ allows us to directly see and understand the disease in the arteries. This helps us make more precise and personalized decisions, which could improve quality of life and prevent heart attacks and strokes.”
The software also has the potential to catch high-risk plaque in patients who aren’t yet showing symptoms, which could lead to earlier interventions and better outcomes. Dr. Mark Rabbat, a cardiologist at Loyola University Chicago, believes that having this kind of data can change how doctors make treatment decisions. “Being able to see the plaque and its components more clearly helps us determine the best course of action for patients, whether that’s medication or sending them for more invasive procedures,” he said.
Elucid’s PlaqueIQ works by processing CT scan images, cleaning up artifacts caused by motion or calcium build-up, and generating a 3D model of the patient’s coronary arteries. The software then identifies and measures different types of plaque, giving doctors a detailed report to work with.
Currently, Elucid is running beta tests of PlaqueIQ and expects to make the software available for limited use by the end of 2024. The company is also working on other applications of its technology, including a non-invasive tool to measure how much a coronary blockage is affecting blood flow.