AGC's Q3 2026 Cardiology Software Market Update

Dear Friends and Colleagues,

The integration of artificial intelligence (AI) in Cardiology is revolutionizing the way heart diseases are diagnosed and treated, promising enhanced accuracy and efficiency in patient care.

Heart disease surpasses cancer as the #1 cause of death in the US. Coronary heart disease is the primary killer; it happens when plaque builds up in the heart arteries causing most heart attacks. Then comes heart failure where the heart muscle becomes too weak or stiff to pump blood. It is a major terminal stage for many cardiac disorders. Cardiovascular disease costs already exceed $500B annually and are on pace to surpass $1T by 2035. Against this backdrop, the Cardiology software market remains fragmented across point solutions for imaging, monitoring, diagnostics, and procedural planning, with no unified platform spanning the patient journey.

AI has helped traverse these siloed workflows and expand the role of software across the cardiac care pathway. The impact of AI has emboldened diagnostic applications to reach areas such as CT angiography, which quantifies coronary plaque buildup, enabling non-invasive diagnosis of coronary artery disease. Use cases of Cardiac AI are bountiful, including applications to measure blood pressure and flow past a coronary artery blockage; these applications are called Fractional Flow Reserve, or FFR. Cardiac AI has extended its growth trajectory to also include market segments like echocardiography, cardiac wearables and implantable devices. Critical to market adoption for Cardiac AI is procedural planning and turning invasive planning into non-invasive procedures. Despite vendor fragmentation across distinct sub-markets, like CT, echo, ECG, or CMR, the AI-enabled cardiology software market is set to grow from ~$1.35B in 2024 to ~$4.75B by 2029.

When speaking about Cardiology AI and clinical advancements in the market, or even the broader HCIT ecosystem, questions often are raised as to reimbursement and FDA approval, notably from potential investors in the field. Given the SaaSpocalypse, the time of reckoning has come. M&A and private placement activity since 2024 in HCIT has outperformed growth trends across the broader technology market. HCIT capital raised is up 12% vs. a 2% decline in broader tech, and M&A deal count is down 5% vs. 9% for broader tech. Our view is that HCIT's regulated nature and human-dependent care delivery insulate it from AI disruption hitting broader tech. For the Report's purposes, Cardiology ranks second only to radiology in AI medical device development, featuring over 200 FDA-cleared algorithms. Imaging and diagnostics dominate approvals, for instance, assisting in echocardiography assessment and automated plaque characterization via FFR. Newer authorizations include algorithms designed to spot hidden structural heart disease or early heart failure risks from routine, standard ECGs before symptoms emerge. Approximately 97% of cardiovascular AI tools clear via 510(k) premarket notification. Further, cardiology AI reimbursement is transitioning from temporary tracking codes into established, direct revenue-generating service lines. CMS is creating dedicated payment pathways, making cardiology one of the leading specialties for clinical AI adoption.

Although the Cardiology software market is fragmented and overshadowed by the large incumbents in medical devices or radiology with the resources to build vs. buy, consolidation in the space has seen increasing awareness among these incumbents of the need to rapidly buy, not build, to quickly gain competitive advantages. We often hear comments coming from the incumbents like, "we are not nimble enough to develop AI-enabled solutions any time soon and will acquire these types of companies." The established medtech and imaging platforms continue to be the most active acquirers, absorbing point solutions with the goal of building an integrated cardiac imaging, diagnostics, or device-monitoring stack rather than competing solution-by-solution. AI-native structural heart and imaging companies command premium multiples, with strategics paying up for FDA-cleared, AI-enabled procedural guidance applications.

AGC continues to be in constant dialogue with and close transactions for leading Cardiology-focused companies looking to navigate the evolving market landscape and position themselves for premium outcomes.