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Cardiology AI Clearances | CVAUSA’s Home Expansion
August 12, 2024
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Together with
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“The digital world has been in a separate orbit from our medical cocoon, and it’s time the boundaries be taken down.”
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Dr. Eric Topol on healthcare’s digital convergence.
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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.
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Where to Go for Cardio AI?
TeraRecon’s Cardio Suite is a collection of hand-selected, vendor-neutral Cardiology AI algorithms that aid in the analysis and interpretation of echocardiograms and chest CTs. Learn about TeraRecon’s AI offering and how they improve efficiency and accuracy here.
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Us2.ai’s Next Gen AI
Us2.ai recently scored FDA clearance for Us2.v2, the newest version of its flagship software featuring 45 automated echocardiography parameters, including strain analysis. See how the new version automates echo exams and improves cardiovascular disease detection.
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Join the Cardiovascular Revolution
See how Optum enterprise imaging can prepare you for the future of imaging with industry-leading structured reporting, single-database architecture, AI and cloud-native design.
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- Pulse Biosciences’ First PFA Treatment: Pulse Biosciences announced the successful treatment of the first two AFib patients using its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System. Pulse Biosciences’ first-in-human feasibility study treated the two patients at St. Antonius Hospital in the Netherlands, achieving effective pulmonary vein and ‘box’ isolation, while producing “linear ablations in a fraction of the time it takes with the current thermal modalities.” Pulse Biosciences is generating some solid momentum, after also landing FDA Breakthrough Device Designation for AFib and adding $83M last month.
- FDA Finalizes TCET Guidance: The FDA published the final guidance on its new Transitional Coverage for Emerging Technologies (TCET) regulatory pathway. TCET is voluntary and is designed to streamline the process for getting breakthrough medical devices to market, but a major potential downside is that rather than automatically allowing Medicare coverage for authorized devices, it requires vendors to go through the cumbersome National Coverage Determination and Coverage with Evidence Development processes. This may limit the number of vendors choosing the TCET pathway.
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Accurately Measuring Heart Rate Variability
Heart rate variability measurement and analysis involves two critical elements – the ability to accurately discern the R wave in noisy environments, and using the correct analysis method for a given application. Check out how Monebo’s Kinetic HRV ECG Algorithm excels at both of these essential tasks.
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Assessing CAD with Circle CVI
Did you know that Circle CVI offers a suite of cardiac CT tools for the assessment of coronary artery disease? See how Circle combines heart function segmentation, automated plaque analysis, CAC scoring, reporting, and viewing in a single dedicated Cardiac CT package.
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HeartFlow FFRCT Avoids Invasive Cath
Despite being conscious about his heart health, 60-year old Mike Gartman suddenly experienced classic symptoms of CAD. See how Mike’s HeartFlow FFRCT Analysis results allowed him to avoid the invasive procedure altogether and gain peace of mind about his disease.
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