– Dr. Paul Dudley White

Artificial Intelligence

AI Clearances Surge, Cardio AI Share Declines

The FDA published its latest Healthcare AI Database last week, featuring a massive 882 AI-enabled medical device clearances, and highlighting some interesting trends in cardiovascular AI.

Overall healthcare AI clearances are gaining momentum, with 2023 bringing a 42% jump in clearances, more than doubling 2022 and 2021’s annual growth (+20% & +16%). 

• However, this growth is in part due to the fact that products must get re-cleared as their algorithms change, and the growth of unique AI products is far more modest.

Cardiovascular AI maintains a (distant) second largest share of FDA-cleared AI products, with 10% of total clearances (90), well below radiology’s 76% share (671).

Cardiovascular AI actually makes up a larger 17.4% share of total clearances (154) if you also count cardiovascular imaging AI products that the FDA technically categorized within its “Radiology” segment (e.g. FFRCT, coronary plaque, etc).

• Even with this broader definition, cardiovascular AI’s total share of AI clearances is declining, falling from roughly 25% of clearances in 2018-2019, to 16.5% in 2020-2022, and 13.5% since the start of 2023.
• Cardiovascular AI’s falling share is partially due to a surge in AI products from new specialties (orthopedics, pathology, urology, ENT), but it’s mainly because non-cardiac radiology AI applications scored a whopping 544 clearances since 2020.

Cardiovascular AI applications also appear to be getting more diverse. Between 2020 and 2022, an overwhelming 86% of all cardiovascular AI clearances were for products that either analyzed imaging or ECG, but imaging and ECG AI’s share of cardiovascular AI clearances fell to 66% in 2023-2024. 

• We’re also seeing cardiovascular AI expand from diagnostics/detection to more procedural use cases, including a growing number of EP ablation mapping products and even AI-enhanced cardiac implants.

The Takeaway

Although the massive growth in healthcare AI clearances far outpaces the actual use of AI in healthcare, these trends are still remarkable and a testament to the huge potential healthcare leaders see in artificial intelligence.

This is of course also true for cardiovascular AI, which might be seeing its share of overall clearances declining, but is still home to some of the most-funded and most-used AI startups, as well as some of the most innovative and clinically relevant AI use cases.

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The Wire

• Semaglutide’s Diuretics Dip: It looks like we can add reducing HFpEF patients’ diuretics requirements to GLP-1s’ growing list of cardiovascular benefits. Analysis of 1,145 patients with and without diabetes in the STEP-HFpEF and STEP-HFpEF DM trials found that loop diuretic use dropped by 17% among HFpEF patients taking semaglutide (Novo Nordisk’s Wegovy/Ozempic), compared with a 2% increase among placebo-takers. 

• Another HeartMate Recall: Abbott’s HeartMate 3 Left Ventricular Assist System (LVAS) is the target of a Class 1 FDA recall after 81 cases of blood leakage or air entering the seal interface between the device inflow cannula and the apical cuff led to 70 reported injuries and two reported deaths. The recall comes just a few weeks after Abbott recalled its HeartMate II and HeartMate 3 systems due to an Extrinsic Outflow Graft Obstruction issue, and two months after Abbott’s related HeartMate Touch Communication System was recalled.

• Elixir’s DynamX Bioadaptor’s 2-Year Advantage: 24-month results from the BIOADAPTOR trial show that Elixir Medical’s DynamX Coronary Bioadaptor System achieved a range of safety and efficacy advantages versus Medtronic’s Resolute Onyx Drug-Eluting Stent. The Elixir DynamX system produced a 65% reduction in target lesion failure rate (1.9% vs. 5.5%), including a 78% reduction in the left anterior descending artery (1.9% vs. 8.7%), while reducing target vessel failure by 68% (1.9% vs. 6.0%). The DynamX Bioadaptor posted similarly strong 12-month results last year.

• InVision LVEF FDA: The echo AI arena welcomed a new competitor last week, following the FDA clearance of InVision Medical Technology’s InVision Precision LVEF solution, which as its name suggests, supports the analysis and reporting of echo-based left ventricular ejection fraction exams. InVision highlighted the new solution’s training and testing in its announcement, noting that it was trained on more echo videos than any other FDA-cleared echo AI model and is the only echo AI product tested in a blinded RCT.

• RESOLVing Side Branch Occlusion in LMV PCI: A new scoring system, LM V-RESOLVE, successfully predicted lesions that were at risk for side branch (SB) occlusion during left main vessel (MV) bifurcation PCI. Among 855 patients, researchers identified three key lesion risk predictors: MV/SB diameter ratio, MV plaque ipsilateral to SB, and baseline SB diameter stenosis. The model had good accuracy (C-statistic of 0.830), helping interventionalists optimize stenting strategies to reduce SB occlusion risk during procedures.

• ADHD Meds and CV Safety: A new JACC study (n=73k) found that patients who took higher doses of ADHD medications (>1 a daily dose) had greater 10-year risks of stroke (2.1% vs 1.7%) and heart failure (1.2% vs 0.7%) compared to prior users of ADHD meds. Patients who never took ADHD meds had the lowest risks. Previous studies have suggested that ADHD medications do or don’t increase cardiovascular risks.

• Meacor’s Valvular Funding: Transcatheter valve repair startup Meacor scored $15M in Series A funding to advance the development of its novel transcatheter mitral and tricuspid valve regurgitation treatments. Meacor’s Cryocinch technology uses on-demand cryoadhesion to support the implantation of interconnected anchors along the valve annulus to effectively stop regurgitation, potentially allowing a range of benefits versus traditional open-heart MR and TR surgeries (shorter recoveries, fewer complications, lower costs).

• PA-Guided HF Therapy: Analysis of MONITOR-HF study data shows that using pulmonary artery pressure to guide heart failure therapy worked across clinical subgroups, supporting its possible role in routine practice to improve quality of life and reduce HF readmissions. Among 348 patients with moderate-to-severe HF, PA-guided therapy (with Abbott’s CardioMEMS system) achieved consistent results across multiple predefined subgroups: age, gender, EF below 40%, etiology, diagnosis of AFib or diabetes, and cardiac defibrillator use. 

• CathWorks FFRangio Lands EU MDR Approval: CathWorks announced that its FFRangio System now has EU MDR approval, leading to its full European launch and the expansion of its co-promotion alliance with Medtronic to Europe. The AI-powered FFRangio solution delivers multi-vessel FFR results from routine angiograms, eliminating the need for invasive pressure wires or drug stimulations. FFRangio was already available in the US and Japan, while its Medtronic alliance stems from a hefty $75M investment nearly two years ago.

• Room to Improve HFrEF GDMT: The TITRATE-HF registry study in the Netherlands found high use of GDMT across HFrEF disease stages, but plenty of room to improve adherence. In 4,288 patients (1,732 de novo, 2,240 chronic, 316 worsening HF), 44% of patients with chronic and worsening HFrEF got quadruple therapy, but only 1% hit their target doses, and quadruple therapy was less commonly given in general cardiology clinics versus dedicated HF clinics. Underuse often came down to side effects, intolerance, or contraindications.

• Full Revasc is FIRE for HBR Patients: The FIRE trial highlighted the advantages of complete revascularization versus culprit-only revascularization in older MI patients with high bleeding risks (HBR) and multivessel disease. In 1,445 patients, HBR doubled these patients’ 1-year risks of major adverse events (HR = 2.01), however, physiology-guided complete revascularization reduced their adverse events by 27%.

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The Resource Wire

• TeraRecon’s Mitral Valve Workflow: Are your mitral valve planning workflows ready for higher procedure volumes? Take this step-by-step tour of TeraRecon’s Mitral Valve Workflow to see how it gives imagers the tools to evaluate the mitral valve and support TMVR treatment planning.

• EHR + Echo AI for HF: See how data analytics and Us2.ai’s echocardiography AI can be used to identify and classify patients with heart failure by tapping into health systems’ EHR. 

• Staging Coronary Artery Disease: Believe it or not, there’s been no clinically relevant atherosclerosis staging system used to characterize heart disease — until now. Check out Cleerly’s four-stage system for evaluating atherosclerotic plaque burden, which is the direct cause of coronary artery disease (CAD).

• PIA Medical Processes It All: Need an analysis like calcium scoring, strain or even FFR? PIA Medical began as a Core Lab and can handle creative cardiac research and clinical trials along with the full breadth of clinical analyses available today.