Curetis wins FDA nod for respiratory infection diagnostic system

Molecular diagnostics company Curetis said today that it won a de novo clearance from the FDA for its Unyvero System and lower respiratory tract infection cartridge. Combined with the cartridge, the Unyvero System evaluates samples for the presence of infectious respiratory disease in under five hours. The device can also tell doctors if it detects any genetic antibiotic resistance markers. Get the full story at our sister site, Drug Delivery Business News. The post Curetis wins FDA nod for respiratory infection diagnostic system appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Diagnostics Food & Drug Administration (FDA) Regulatory/Compliance Respiratory curetis Source Type: news