Smartphone “Dongle” Achieves Capabilities of Big Clinical Laboratory Analyzers: Diagnoses Three Diseases at Once from Single Drop of Blood

This breakthrough in technology miniaturization holds great promise for improving public health, but portends a disruptive future ahead for the medical labs  Is the medical laboratory industry ready for a handheld device that can do immunoassay testing without requiring any stored energy? The secret of this device, already undergoing field trials in Rwanda, is that it uses a smartphone accessory, or “dongle,” to capture and transmit the results of the lab tests. This innovative smartphone...

FDA’s Unique Device Identifier Program for In Vitro Diagnostic Devices Used by Clinical Laboratories Set to Begin September 24

Donor screening assays and in vitro diagnostic tests, including laboratory-developed tests, are now classified as IVDs and require a UDI label Later this month, a new Food and Drug Administration (FDA) rule will take effect that requires unique device identifiers (UDIs) on most medical devices. This will include analyzers, instruments, and automated systems used by clinical laboratories and anatomic pathology labs. UDIs also will apply to certain combinations of products that contain devices...

Immunoassay and Infectious Disease Analyzers Evaluated during Use by Clinical Pathology Laboratories

Industrial engineering firm issues “Consumer Report”-type assessment of mid-volume, automated IA and ID analyzer systems It’s not often that pathologists and clinical laboratory managers can access a Consumer Reports-type of comparison of laboratory analyzers as they prepare to purchase new diagnostic systems. In the case of mid-volume analyzers for immunoassy (IA) and infectious disease (ID) testing, such a report is now available—and it is immediately available on the Web. The report is...
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