Artificial Intelligence

Healthcare AI Clearances Boom, While Cardiology AI Stalls

The FDA’s annual Healthcare AI Report had medtech social media buzzing this week, showing that an impressive 692 AI-enabled devices have landed FDA clearance as of July 2023, while revealing an apparent slowdown in cardiovascular AI approvals. 

Healthcare AI clearances are gaining momentum, with over 30% growth projected for 2023 (already +18.5% through July). That would double 2022 and 2021’s annual growth (+14% & +15%), and potentially rival 2020 (+39%).

Cardiovascular AI has the second largest share of FDA-cleared AI products, with 10% of total clearances based on the FDA’s categorization (71), well below radiology’s 76% share (531).

  • However, cardiovascular AI actually makes up a larger 18% share of total clearances (124) if you count cardiovascular imaging AI products that the FDA categorized within the “Radiology” segment (e.g. echo AI, FFR-CT, coronary plaque, etc). 

Even with this broader definition, cardiovascular AI’s total share of AI clearances is declining, falling from roughly 26% of clearances between 2016 and 2019 to around 16% since 2020.

  • Cardiovascular AI’s falling share is partially due to a surge in AI-enabled products from new specialties (orthopedics, pathology, GI & urology, ENT), but it’s mainly because non-cardiac radiology AI applications scored a whopping 368 clearances since 2020.
  • However, the large and growing field of cardiology AI startups suggests that more cardiovascular AI clearances are on the way.

ECG has become the most common cardiovascular AI modality (28%, 34 clearances), due in part to its diverse use cases and data sources (smartwatches, personal monitors, hospital-grade ECG systems, etc).

  • A notable 52% of cardiovascular AI devices focus on medical imaging, largely driven by CT and ultrasound AI products (25 & 29 clearances).

The Takeaway

The growth we’re seeing in healthcare AI clearances is remarkable, and a testament to the massive upside both major medtech conglomerates and VC-backed startups see in the technology.

The same is true for cardiology AI, which might be stuck with a distant second share of FDA clearances, but also has among the most diverse and commercially-viable AI products on the market today.

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