The FDA updated its healthcare AI database last week, increasing its list of AI-enabled clearances to a whopping 950 medical devices, while highlighting some interesting trends in cardiovascular AI.
Overall healthcare AI clearances seem to be stable, with the first half of 2024 bringing 107 total clearances, which is just behind pace of 2023’s full year total (220).
Cardiovascular AI maintained a distant second largest share of FDA-cleared AI products in H1 2024, with 9% of total clearances (10 devices), well below radiology’s 73% share (78 devices).
However, cardiovascular AI actually made up a larger 18% share of total H1 2024 clearances (19 devices) if you also count cardiovascular imaging AI products that the FDA technically categorized within its “Radiology” segment (e.g. FFRCT, coronary plaque, echo AI, etc)…We’re using this broader definition of cardio AI through the rest of this story.
- Cardiovascular AI’s total share of H1 2024 AI clearances was the highest since 2020 (both 18%), after landing between 14% and 16% during the last three years.
- Cardiovascular AI’s 19 clearances in H1 2024 also puts the segment on pace to eclipse any previous year (previously 30, 24, 21, 20, 22, 15).
The FDA database also reveals extremely wide brand diversity in the cardiovascular AI segment, with 86 companies, and none with more than a 6% share of total clearances.
- That trend stayed alive in H1 2024, which saw another influx of new cardio AI developers making their debut on the FDA list (AgileMD, DASI Simulations, inHEART, InVision Medical, Innolitics, Kestra Medical… and even the US Army).
Cardiovascular AI applications continued to largely analyze imaging and ECG data, although imaging+ECG’s share of cardio AI clearances fell to 74% in H1 2024 (down from 83% in 2023 and 88% in 2022) due to a recent increase in EHR and sensor-based cardio AI products.
- We’re also seeing cardiovascular AI continue to expand from diagnostics/detection to more procedural use cases, including new solutions for TAVR and ablation planning that were cleared in H1 2024.
The Takeaway
Although actual cardiovascular AI use in the clinic is in its early stages, the large and growing list of FDA-cleared cardio AI products is a reminder of the innovations taking place in this arena. That innovation appears to be leading to more cardiovascular AI products, with more diverse use cases, and should eventually lead to larger increases in clinical adoption.
