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 [...]
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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 [...]
2025-10-22
Private Internet Access VPN review: Both more and less than a budget VPN
I came into this review thinking of Private Internet Access (PIA) as one of the better VPNs. It's in the Kape Technologies portfolio, along with the top-tier ExpressVPN and the generally reliable [...]
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 [...]
2025-09-12
Apple Watch Series 11 receives FDA approval 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 [...]
2025-02-03
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 [...]