2025-05-10
FDA approves at-home pap smear alternative device for cervical cancer screening
The Food and Drug Administration has approved a new device called the Teal Wand, which its creator describes as an "at-home vaginal sample self-collection device for cervical cancer screening." It could be especially useful for women who find pap smears uncomfortable, painful and even traumatic, as well as for those who may not have time to go to [...]
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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
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 [...]