Abbott's i-STAT TBI cartridge has received clearance from the U.S. Food and Drug Administration (FDA) to be used with whole blood, allowing doctors to help assess patients with suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests to help with the assessment of TBI were only cleared for use with plasma or serum, requiring samples to be sent to a lab for processing and testing.
C₂N Diagnostics, LLC, a leader in advanced brain health diagnostics, and Eisai Inc., a “human health care company,” have announced Eisai has made an investment of up to 15 million USD in C₂N.
Researchers at the Washington University in St. Louis and Lund University in Sweden have taken a step closer toward developing a blood test that could be used during an annual doctor’s office visit to help catch cases of Alzheimer’s disease.
Analysis of molecules that travel from the brain into the blood could enable noninvasive monitoring of gene expression in the organ, according to research published in Nature Biotechnology.
A menstrual pad designed with a removable strip to collect blood samples for clinical tests has been granted clearance by the US Food and Drug Administration (FDA).
DiaCarta announced on Tuesday that its over-the-counter fecal occult blood test has received 510(k) clearance from the US Food and Drug Administration.
Burning Rock Biotech Limited (NASDAQ: BNR and LSE: BNR, the “Company” or “Burning Rock”) is pleased to announce that followed an earlier Breakthrough Device Designation granted by the US Food and Drug Administration (FDA) for its OverC™ Multi-Cancer Detection Blood Test (MCDBT) in January 2023, its OverC™ MCDBT has been granted Breakthrough Device Designation by the China National Medical Products Administration(NMPA), which represents the only test globally that has received Breakthrough Device Designation from both US FDA and China NMPA.
U.S. genetic testing company Illumina (ILMN.O) has been ordered by EU antitrust regulators to sell cancer test maker Grail (GRAL.O) after it completed the deal before securing their approval.
Labcorp (LH.N) on Wednesday began marketing to U.S. physicians the first test for a trio of blood biomarkers it says can detect the hallmarks of Alzheimer's, accelerating diagnosis of the brain-wasting disease and potentially helping patients access treatment.
Laboratory services provider Stone Diagnostics will offer Fibronostics' artificial intelligence-based liver disease test to physicians in the US, the companies announced on Tuesday.
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