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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Gain in-depth knowledge of fluoroscopic anatomy and cutting-edge imaging techniques with renowned expert, Dr. Nicolo Piazza. This five-session master class is happening now through November. Register now!
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