The FDA’s public “reminder” that studies analyzed by AI-based LVO detection tools (CADt) still require radiologist interpretation became one of hottest stories in radiology last week, and although many of us didn’t realize, it made a big statement about how AI-based coordination is changing the way care teams and radiologists work together.
The FDA decided to issue this clarification after finding that some providers were using LVO AI tools to guide their stroke treatment decisions and “might not be aware” that they need to base those decisions on radiologist interpretations. The agency reiterated that these tools are only intended to flag suspicious exams and support diagnostic prioritization, revealing plans to work with LVO AI vendors to make sure everyone understands radiologists’ role in these workflows.
This story was covered in all the major radiology publications and sparked a number of social media discussions with some interesting theories:
- One social post suggested that the FDA is preemptively taking a stand against autonomous AI
- Some posts and articles wondered if AI might be overly-influencing radiologists’ diagnoses
- The Imaging Wire didn’t even mention care coordination until a reader emailed with a clarification and we went back and edited our initial story
That reader had a point. It does seem like this is more of a care coordination issue than an AI diagnostics issue, considering that:
- These tools send notifications and images to interventionalist/surgeons before radiologists are able to read the same cases
- Two of the three leading LVO AI care coordination tools are marketed to everyone on the stroke team except radiologists (go check their sites)
- Before AI care coordination came along, it would have been hard to believe that stroke team members “might not be aware” that they needed to check radiologist interpretations before making care decisions
The Takeaway
LVO AI care coordination tools have been a huge commercial and clinical success, and care coordination platforms are quickly expanding to new use cases.
That seems like good news for emergency patients and care teams, but as the FDA reminded us last week, it also means that we’re going to need more safeguards to ensure that care decisions are based on radiologists’ diagnoses — even if the AI tool already informed care teams what the diagnosis might be.
