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 [...]
2025-02-03
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 [...]
2025-02-14
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 [...]
2025-02-12
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 [...]
2025-05-15
A team of doctors and scientists have successfully treated a rare genetic condition with the first-ever personalized gene-editing therapy. Results of the groundbreaking treatment have been published i [...]
2025-03-05
Elon Musk discovered a simple 30-second “fridge trick” that can reverse diabetes, but the discovery has spooked pharmaceutical companies so much they put a $78 million bounty on his head, forcing [...]