2025-05-16
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 [...]
2025-06-03
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 [...]
2025-09-15
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 [...]
2025-07-23
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'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
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 [...]
2025-08-21
Masimo, the medical technology company whose lawsuit led to the temporary sales pause of the Apple Watch Series 9 and Ultra 2, has sued the US Customs and Border Protection days after Apple released i [...]