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.

French diagnostics firm BioMérieux said Wednesday that it has received 510(k) clearance from the US Food and Drug Administration for its BioFire SpotFire Respiratory/Sore Throat (R/ST) test panel.

The US Food and Drug Administration announced last week that Roche's Cobas Malaria test has been approved by the agency.

Diagnostic test maker Technoclone on Tuesday said it has secured US Food and Drug Administration de novo marketing authorization for a test that is used to aid the diagnosis of a rare, life-threatening blood-clotting disorder.

Danaher subsidiary Beckman Coulter Life Sciences announced Tuesday that its DxFlex Clinical Flow Cytometer has received 510(k) clearance from the US Food and Drug Administration.

DiaSorin has received the US Food and Drug Administration’s 510(k) clearance for its LIAISON PLEX platform and the accompanying LIAISON PLEX Respiratory flex assay.

The US Food and Drug Administration last week granted Emergency Use Authorizations for two point-of-care COVID-19 and influenza combination tests developed by Sekisui Diagnostics.

French diagnostics firm Sebia said Thursday that it has received US Food and Drug Administration 510(k) clearance for its FLC Kappa and Lambda assays.

EnsoData has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine learning-based diagnostic for sleep apnea and other sleep disorders that uses data from pulse oximetry (pulse ox) devices.

The US Food and Drug Administration on Tuesday issued a letter to medical device manufacturers and sponsors of device studies warning them to independently verify performance test results before submitting them to the agency due to concerns about fraudulent results.