Healthcare AI is entering clinical practice faster than the evidence framework can evaluate it. FDA has cleared over 1,451 AI-enabled medical devices. Digital health companies are publishing clinical data at unprecedented scale. And new regulatory pathways like the Predetermined Change Control Plan (PCCP) are creating adaptive frameworks for AI that evolves after deployment.
But what does the evidence actually prove? What’s the difference between a vendor’s internal validation study and a prospective randomized controlled trial? How do you evaluate whether an AI health platform has enough clinical evidence to trust with patient care?
This guide maps the clinical AI evidence landscape — from the evidence pyramid that classifies proof quality, to the regulatory pathways governing AI devices, to the companies building the strongest (and weakest) evidence bases in digital health.
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AI in healthcare is supposed to upend diagnostics and patient care, but in cardiology, that talk is cheap without rigorous clinical validation. So here’s the…
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The way we regulate AI in cardiology is changing completely. We’re moving from a world of one-time, static approvals to a more dynamic model that…
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AI in ECG interpretation is here, and it’s creating a common headache for cardiologists. What do you do when an AI-enabled ECG flags a patient…
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AliveCor’s remarkable achievement of 39 FDA cardiac determinations raises critical questions about the durability of investment in the FDA Center for Devices and Radiological Health…
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The intersection of artificial intelligence and healthcare is rife with both unparalleled promise and significant regulatory complexities. As capital flows into this burgeoning sector, investors,…
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The clamor from clinicians and investors for actual clinical evidence in cardiovascular AI platforms is getting louder. With all the promises about AI revolutionizing heart…
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AI is bringing new tools to cardiovascular care, offering the possibility of earlier detection, personalized treatments, and better patient outcomes. But for clinicians and cardiologists…
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We keep hearing about AI in healthcare, with the idea that algorithms can see patterns doctors can’t and predict disease before it hits. For a…
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