The first blood test used to diagnose Alzheimer’s disease was cleared by the Food and Drug Administration for marketing Friday, meaning the laboratory test can be marketed and sold in the U.S ...

The US Food and Drug Administration (FDA) has granted 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for Visby Medical’s polymerase chain reaction (PCR) test to ...

SMARTOX has deployed 50+ fingerprint drug screening devices and completed 7,000+ tests, including 1,500 in 2024 alone. Intelligent Bio aims to expand into workplace testing pending FDA clearance ...

T he US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid ...

Intelligent Bio reported a third-quarter 2025 loss of 44 cents per share, down from a loss of $1.43 a year ago.. The noninvasive testing solutions provider reported sales of $728.87 thousand, down ...

A blood test made by a Malvern company that can help diagnose Alzheimer's disease, a form of dementia affecting more than 7 million Americans, has been cleared by the U.S. Food and Drug ...

In a promising development, Intelligent Bio Solutions has reported initial results from a Pharmacokinetic study, a crucial step toward FDA 510(k) clearance for its non-invasive drug screening system.

The University of Alabama at Birmingham startup TIXiMED, Inc., has obtained clearance from the United States Food and Drug Administration to proceed to clinical trials under an Investigational New ...

The Food and Drug Administration has given marketing clearance to the first blood test to help diagnose Alzheimer’s disease. On May 16, ...

SMARTOX has deployed over 50 of INBS’ Intelligent Fingerprinting Drug Screening Readers and facilitated over 7,000 screening tests, including more than 1,500 tests in 2024 alone Company ...