McLaren Health Deploys AI for Cardiac CT
Michigan-based McLaren Health Care has launched an artificial intelligence tool from Cleerly that reviews CT scans for early signs of heart disease. The deployment exemplifies a trend toward using AI for opportunistic screening, analyzing routine imaging to identify high-risk patients for conditions beyond the initial scope of the exam.
- The Cleerly software is designed to analyze coronary CT angiography (CCTA) scans to quantify and characterize plaque, assess stenosis, and determine the likelihood of ischemia. Its algorithms are based on data from over 15 years of multicenter clinical trials involving more than 50,000 patients. - In March 2024, the U.S. FDA granted Cleerly's CAD Staging System a Breakthrough Device Designation and accepted it into the Total Product Life Cycle Advisory Program (TAP) Pilot to help expedite patient access. The company also received 510(k) clearance for its Cleerly ISCHEMIA software. - A significant driver for the adoption of cardiac CT and associated AI is a 2025 Medicare reimbursement change that nearly doubled the payment for CCTA under the Hospital Outpatient Prospective Payment System (HOPPS), increasing the national rate from approximately $175 to $357. - Projections indicate that advanced imaging will grow by nearly 14% over the next decade, with CT scans specifically expected to increase by 15%. This growth is happening as care continues to shift to non-hospital settings, with roughly 40% of all radiology volume now performed in outpatient imaging centers. - AI integration is a key strategy to mitigate radiology staffing shortages and burnout, which are worsening due to increased exam complexity and decreasing reimbursements. Studies have shown AI can increase reporting efficiency by an average of 15.5%, with some radiologists experiencing up to a 40% improvement without compromising accuracy. - Health systems are increasingly developing "systemness" strategies for imaging, coordinating services across networks of hospitals and outpatient sites, including freestanding and mobile imaging centers, to capture growth and improve efficiency. - The diagnostic imaging services market in the U.S. is projected to grow from approximately $149.5 billion in 2025 to nearly $240 billion by 2032. The hospital outpatient (HOPD) segment is expected to expand at the highest rate due to cost-effectiveness and convenience. - For AI-driven plaque analysis specifically, a new Category I CPT code is anticipated to be introduced in January 2026, which is expected to further accelerate the adoption of these technologies.
