FDA clears Elucid's PlaqueIQ image analysis software

The U.S. Food and Drug Administration (FDA) has cleared Elucid's PlaqueIQ image analysis software for cardiovascular disease assessment.

The software quantifies and characterizes noncalcified plaque and its components such as lipid-rich necrotic core found on coronary CT angiography (CCTA) imaging, the company said. Users send patient images to Elucid, which then applies PlaqueIQ's image-restoration algorithms to the file to mitigate motion and calcium blooming artifacts.

Elucid plans to release PlaqueIQ later in the fourth quarter of this year. It is also pursuing clearance from the FDA for measurement of fractional flow reserve derived from PlaqueIQ technology, it said.