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Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance

TUCSON, Ariz., March 21, 2025 /PRNewswire/ -- Accelerate Diagnostics, Inc. (Nasdaq: AXDX), an innovator in rapid in vitro diagnostics for microbiology, today announced the submission of its Accelerate ...
Yahoo Finance

Accelerate Diagnostics Stock Down Despite FDA Clearance for Arc System

Accelerate Diagnostics, Inc. AXDX has secured FDA 510(k) clearance for its Accelerate Arc system and BC kit, designed for use with Bruker's MALDI Biotyper CA system (MBT-CA System) and MBT-CA ...
Business Wire

Hologic Announces First and Only FDA-Cleared Digital Cytology System – Genius™ Digital Diagnostics System

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that its new Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm has received clearance from the ...
Business Wire

Hologic Announces European Launch of Genius™ Digital Diagnostics System for Cervical Cancer Screening

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. (Nasdaq: HOLX) announced today that its new Genius™ Digital Diagnostics System is now commercially available in Europe. The Genius Digital ...