FDA clears AI-enabled CCTA plaque analysis tool from Keya Medical
The U.S. Food and Drug Administration (FDA) has cleared Keya Medical's DeepVessel Plaque quantitative coronary plaque analysis and stenosis assessment from noninvasive coronary CT angiography (CCTA) imaging.
The company, which has offices in the United States and China, is the newest addition to a growing number of vendors now offering image-based artificial intelligence (AI) plaque assessments as a more accurate way to risk stratify patients. Keya previously gained FDA clearance for its CT-derived fractional flow reserve (FFR-CT) algorithm in April 2022. With this new approval now in place, the company offers both anatomical and functional assessments from a single CCTA scan.
The FDA clearance was supported by a multicenter U.S. clinical validation study. Keya said this research demonstrated excellent agreement with expert-reader consensus for plaque quantification and stenosis assessment. The full results of that trial will be presented by Matthew Budoff, MD, and investigators from The Lundquist Institute at the SCCT2026 meeting in San Diego.
"DeepVessel Plaque adds to the growing tools we have to identify and quantitate plaque on coronary CT in our patients better, allowing more precise risk stratification and more effective application of preventive therapies," Budoff said in a statement.
The algorithm is indicated for adults 22 years old and older with suspected or known coronary artery disease who have undergone CCTA imaging. The AI generates a plaque analysis report that include measurements for total plaque volume, calcified plaque volume, non-calcified plaque volume, low-density plaque volume, plaque burden measurements, and vessel segment-level and patient-level analysis.
The report also includes CAD-RADS categorization and an AI-powered vessel and lumen segmentation diagram
Many CCTA experts believe AI plaque analysis will open new, more accurate individualized coronary artery disease (CAD) assessments, and possibly change how patients are screened for preventive therapies. This includes the ability to catch disease much earlier and monitor the progression or regression of disease after treatment through serial scans of patients over time.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]