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Nearly Half of FDA-Approved AI Devices Not Based On Real Patient Data

September 22, 2024 Posted by Director Environment & Engineering, Progress & Principles, Robotics & AI

Nearly Half of FDA-Approved AI Devices Not Based On Real Patient Data The study, published in Nature Medicine, found that nearly half of AI medical devices authorized by the FDA were not based on real patient data. Researchers recommend the FDA require clinical validation for all devices, meaning testing on real patients so scientists can see that they actually work.

SOURCE MATERIAL: https://www.nature.com/articles/s41591-024-03203-3

RELATED MATERIAL: https://participatorymedicine.org/epatients/2012/03/former-nejm-editors-on-the-corruption-of-american-medicine-ny-times.html.

Former editor of the New England Journal of Medicine, Marcia Angell, M.D., said this over a decade ago… “It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.”

The FDA granted emergency use authorization (EUA). And the FDA changed the definition of ‘vaccine’ because gene therapies require safety testing. AstraZeneca and J&J are adenoviral vector DNA technology. Pfizer & Moderna are synthetic mRNA technology.

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