Of more than now >1,000 FDA-cleared medical A.I. algorithms, the vast majority are for radiology, 97% were cleared by 510(k) pathway (=not "approved"), and <10% were tested with any human operator https://
jamanetwork.com/journals/jaman
etworkopen/fullarticle/2841066?utm_campaign=articlePDF&utm_medium=articlePDFlink&utm_source=articlePDF&utm_content=jamanetworkopen.2025.42338
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@erictopol
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FDA-Cleared Medical AI Algorithms Lack Adequate Human Testing
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Multi-Cancer Early Detection Test Results Questioned
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The headlines and the press release are misleading. It is hard to label these results as "transformative" when such few early cases were detected, at great expense, and potential of false negatives. I am sanguine for the future of multi-cancer early detection tests, but they need
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AI Cancer Detection Achieves 5.7 Cases Per 1,000 Persons
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This translates to detecting 5.7 cases of cancer for every 1,000 persons tested
Of these, 3 cases of early cancer (Stage 1/2) were detected for every 1,000 persons tested -
Galleri Blood Test AI Detects Cancer Seven Times More Effectively
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This is the company's press release https://
grail.com/press-releases
/grail-pathfinder-2-results-show-galleri-multi-cancer-early-detection-blood-test-increased-cancer-detection-more-than-seven-fold-when-added-to-uspstf-a-and-b-recommended-screenings/
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Galleri Blood Test Trial Shows Multi-Cancer Early Detection Results
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Let's talk about the results of a new, large trial of a multi-cancer early detection blood test called Galleri, which costs $949, that enrolled 35,878 participants in the US and Canada aged 50+. Here is the registration: https://
clinicaltrials.gov/study/NCT05155
605?term=PATHFINDER2&rank=7
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These are the headlines -
AI and CRISPR revolutionizing the future of medicine
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On A.I., CRISPR and the future of medicine with @DoudnaJennifer and James Manyika https://
youtube.com/watch?v=I46yPX
jk6cc
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GPT-5 and Medicine: Status Summary from Nature
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On GPT-5 and medicine, status summary https://
nature.com/articles/s4159
1-025-04008-8
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Breakthrough Blood Test Predicts Alzheimer’s Disease Progression
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The single blood test that "not only indicated
how advanced the disease was but also helped to predict its [Alzheimer's disease] progression." https://
nature.com/articles/s4358
7-025-00951-w
… and more here https://
erictopol.substack.com/p/the-breakthr
ough-blood-test-for-alzheimers
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AI and physician de-skilling: Lancet analysis of solutions
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Will A.I. lead to de-skilling of physicians?
And if so what can be done to preempt it? @tberzin and I address this in a new @TheLancet piece https://
thelancet.com/journals/lance
t/article/PIIS0140-6736(25)02075-6/abstract
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Genome Sequencing Identifies Cancer Pathogenic Variants in 5% Population
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At least 5% of people have cancer pathogenic gene variants via genome sequencing , a consistent finding among several large cohorts https://
jamanetwork.com/journals/jama/
fullarticle/2840089i
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