A new automation system from Abbott, designed to improve workflows in clinical lab settings, has been granted FDA approval.
Lab
The American Hospital Association is urging the FDA not to move forward with a proposed rule to treat laboratory-developed tests as medical devices, saying the move would disrupt innovation and potentially increase hospital costs.
Standard hospital urine drug analyses do not test for current popular drugs that lead to fatal overdoses, leading to missing diagnoses, according to an opinion piece published Nov. 15 in Scientific American.
New Hyde Park, N.Y.-based Northwell Health has unveiled a three-in-one swab to test for COVID-19, flu and respiratory syncytial virus.
Hackensack Meridian Health is spinning off its first company based on science from its research institute, the Edison, N.J.-based system said Oct. 4.
Quest Diagnostics was recently granted a breakthrough device designation from the FDA for its adeno-associated virus test.
The CDC could restructure its lab operations under recent recommendations made by its Laboratory Workgroup.
The CDC plans to overhaul its lab operations after mishaps with its COVID-19 test, KFF Health News reported Aug. 21.
Three of Orlando (Fla.) Health's laboratories recently received accreditation from the College of American Pathologists.
Quest Diagnostics acquired assets from NewYork-Presbyterian' lab business in an all-cash transaction for $275 million, according to financial documents filed July 27 with the Securities and Exchange Commission.