资讯

FDA grants 510(k) clearance to Fujirebio’s blood-based test for Alzheimer’s
The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 ...
FDA greenlights first blood test to help diagnose Alzheimer’s disease in the US
The US Food and Drug Administration has given marketing clearance to a blood test to help diagnose Alzheimer’s disease, ...
华尔街见闻 on MSN2 天
FDA批准首个用于诊断阿尔茨海默氏症的血液检测技术
美国食品药品监督管理局（FDA）周五表示，该机构已批准Fujirebio ...
FDA批准首个阿尔茨海默病血液诊断测试
Investing.com — 美国食品药品监督管理局 (FDA)已授权首个基于血液的诊断工具，用于帮助检测出现认知能力下降迹象和症状的成年人的阿尔茨海默病。Lumipulse G pTau217/ß-Amyloid ...
腾讯网2 天
美国FDA首次批准血液检测阿尔茨海默病，无创早筛新时代正式到来
2025年5月份，美国食品药品监督管理局（FDA）正式批准了一款由日本生物技术公司 Fujirebio Diagnostics ...
FDA endorses first-of-its-kind blood test for Alzheimer’s disease
The Food and Drug Administration cleared a new kind of test for Alzheimer’s disease designed to be more accessible and less ...
Express Healthcare4 小时
FDA approves first blood test to support Alzheimer’s diagnosis
The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio enables early detection of amyloid plaques through a non-invasive blood ...
pharmaphorum11 小时
FDA clears first blood test for Alzheimer's disease
The FDA has approved the first blood test for Alzheimer's disease based on a blood test – from Fujirebio – in a step forward ...
FDA clears first blood test to detect Alzheimer's disease. What to know about Lumipulse.
The Lumipulse Alzheimer's blood test is the first of a new generation of tests that may replace brain scans and spinal taps to detect the disease.
Fierce Biotech2 天
FDA clears its first blood test for diagnosing Alzheimer's disease, with Fujirebio's Lumipulse
The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that ...
First blood test for Alzheimer’s diagnosis cleared by FDA
The FDA has cleared the first-ever blood test for early Alzheimer's detection, which the agency says reduces the need for ...
US FDA approves world’s first blood test for Alzheimer’s, and what it means
The FDA has approved the Lumipulse Plasma Ratio test, a groundbreaking blood test for early dementia detection. This less ...