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 disinformation and pushbacks against science, but why not rush things through with AI?
Elsa — yes, weirdly like the snow queen from Frozen — completed a "very successful pilot program with FDA’s scientific reviewers." According to the FDA, the AI tool can help with reading, writing and summarizing everything from adverse events to assessments. Elsa can also do label comparisons and generate code. It's already being used [...]
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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
Nuance Audio, new "hearing glasses" from EssilorLuxottica, have received FDA clearance and "a CE marking under the Medical Devices regulation in the EU," making them officially rea [...]
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 [...]
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 [...]