Abbott (NYSE: ABT) announced today that Health Canada has approved the company's i-STAT TBI test cartridge for use with whole blood, helping clinicians to assess suspected concussion at the patient's bedside and obtain lab-quality results in 15 minutes. Previously, the tests used to help assess mild traumatic brain injury (mTBI) were only authorized for use with plasma or serum, requiring samples to be sent to a lab for processing.

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, today announced a collaboration with The University of Texas MD Anderson Cancer Center (MD Anderson) designed to improve the assessment of elevated risk of cancer in individuals who would benefit from medically appropriate cancer screenings.

Diasorin (FTSE MIB: DIA) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the LIAISON PLEX® Gram-Positive Blood Culture Assay, the final syndromic blood culture panel for the microbiological diagnosis of bloodstream infections on the LIAISON PLEX®.

Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield multi-cancer detection (MCD) test has been granted Breakthrough Device designation from the U.S. Food and Drug Administration (FDA). The Shield MCD test is a methylation-based blood test for the multi-cancer screening of multiple cancer types including bladder, colorectal, esophageal, gastric, liver, lung, ovarian and pancreas cancer in individuals aged 45 or older who are at typical average risk for cancer.

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer’s Disease (AD).

Diasorin (FTSE MIB: DIA) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the second1 of its 3 multiplex molecular panels for blood culture pathogen identification on the LIAISON PLEX® system.

Augurex Life Sciences Corp., a leader in autoimmune biomarker-based diagnostics, today announced that Health Canada has approved SPINEstat™, a first-in-class diagnostic blood test for axial spondyloarthritis (axSpA), as a Class II medical device. By detecting auto-antibodies to the 14-3-3eta protein, SPINEstat™ provides an important new clinically validated and objective biomarker to aid in the early and accurate diagnosis of axSpA.

Quest Diagnostics (NYSE: DGX), a leader in diagnostic information services, including advanced diagnostics for brain health, today announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or dementia.

Dutch diagnostics firm MRC Holland said Friday that two of its blood-based assays for spinal muscular atrophy (SMA) have been certified under Europe's In Vitro Diagnostic Regulation (IVDR).

Home testing firm LetsGetChecked announced on Tuesday that its ImPress lancing device has received 510(k) clearance from the US Food and Drug Administration for professional use.