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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