2025-05-16
The FDA clears the first blood test for diagnosing Alzheimer's disease
There's a new way to screen for early detection of Alzheimer's disease. On Friday, the Food and Drug Administration (FDA) cleared the first blood test for the disorder. Fujirebio Diagnostics' Lumipulse measures the ratio of two proteins that correlate with the presence or absence of Alzheimer's. Previously, patients being screened for Alzheimer's were limited to more invasive options: a PET Scan or spinal tap.
Lumipulse is intended for use in clinical settings with patients exhibiting signs of cognitive decline. At least in its current form, it isn't something [...]
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2025-06-03
The FDA rolls out its own AI to speed up clinical reviews and scientific evaluations
The FDA has launched the generative AI tool, Elsa, agency-wide to help its employees with everything from clinical reviews to investigations. Sure, we're living in a time of widespread disinforma [...]
2025-07-23
FDA employees say the agency's Elsa generative AI hallucinates entire studies
Current and former members of the FDA told CNN about issues with the Elsa generative AI tool unveiled by the federal agency last month. Three employees said that in practice, Elsa has hallucinated non [...]
2025-02-03
The FDA and EU clear Nuance Audio, smart glasses with built-in hearing aids, for sale
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2025-02-14
Trump administration adds note rejecting 'gender ideology' to government websites
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2025-02-12
Court orders the CDC and FDA to restore deleted web pages related to gender identity
US District Judge John D. Bates has ordered (PDF) the Center for Disease Control and Food and Drug Administration to restore the web pages and resources they had previously removed to comply with Pres [...]