The AST system was granted 510(k) clearance along with an assay to detect Gram-negative bacteria directly from positive blood cultures.
The rule could boost Roche's planned launch of an FDA-cleared mass spec system while requiring other vendors to rethink their ...
To reduce the environmental impact caused by conventional lateral flow tests, several companies and institutions have been ...
Last week, readers were most interested in a story about Roche's four-in-one molecular test receiving Emergency Use Authorization from the FDA.
The US Food and Drug Administration has established an enforcement discretion policy for LDTs approved in New York, setting up an alternative path to market.
The Healgen COVID-19/Flu A&B Combo Rapid Test Cassette is used for the detection and differentiation of SARS-CoV-2 and flu A/B nucleocapsid protein antigens.
The Ventana assay previously received CE marking for identifying patients with lung cancer who may benefit from treatment with Libtayo.
The agency cleared new devices including syndromic panels for infectious diseases and digital pathology software as well updates to previously cleared tests.
Upssala, Sweden-based Sysmex Astrego won the Longitude Prize for the PA-100 AST System that delivers antibiotic susceptibility test results in 45 minutes.
The agency granted authorization for over-the-counter and point-of-care tests that are used for the detection and differentiation of SARS-CoV-2 and flu A/B.
NEW YORK – The US Attorney's Office for the Central District of Illinois said this week that a grand jury has indicted an Illinois lab CEO on multiple counts of fraud for allegedly running an illegal ...
NEW YORK – Bolstered by recent deals to acquire lab operations and license digital pathology technologies from PathAI, Quest Diagnostics plans to accelerate its transition to digital pathology across ...