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 nonexistent studies or misrepresented real research. "Anything that you don't have time to double-check is unreliable," one source told the publication. "It hallu [...]
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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 [...]
2025-02-12
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 [...]
2025-02-03
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 [...]
2025-09-15
Apple Watch Series 11 receives FDA clearance for hypertension alerts
Apple's Awe Dropping event started with dramatic health testimonials from Apple Watch users, then revealed a key new feature for the new Watch Series 11: hypertension alerts. The function had yet [...]
2025-02-14
Trump administration adds note rejecting 'gender ideology' to government websites
Newly restored pages on the websites of government agencies like the Food and Drug Administration (FDA) and Substance Abuse and Mental Health Services Administration (SAMHSA) now include a disclaimer [...]
2025-07-24
FDA is using an AI system that staff say frequently invents or misrepresents drug research
The US Food and Drug Administration is relying on Elsa, a generative AI system, to help evaluate new drugs - even though, according to insiders, it regularly fabricates studies.<br /> The articl [...]