Sep 10, 2014 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
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 licensed under the Public Health Service Act (PHSA), such as donor screening assays and in vitro diagnostic (IVD) testing, including laboratory-developed tests (LDTs), noted a document describing the new law on the FDA website. (more…)
Dec 2, 2013 | Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Pathology, News From Dark Daily
Clever entrepreneur thinks up inventive way to truly do clinical laboratory tests at the ultimate point of care and use a smart phone application to alert the doctor
With the advent of digital technology and smartphones, medical laboratory testing is moving out of the central laboratory and into the bedside, homes and now into diapers! A new digital “Smart Diaper” invented by New York startup Pixie Scientific constantly monitor’s a baby’s health to detect urinary tract infections, kidney problems, or dehydration early, before the health issue escalates.
‘Smart Diaper’ Tweets When It Detects a Health Problem (more…)
Dec 9, 2009 | Laboratory News, Laboratory Pathology
There’s a green bonus: GenVault’s new storage systems can reduce a clinical laboratory’s carbon footprint
Innovative laboratory technologies continue to disrupt the status quo as new products and services enter the marketplace. Among them is new dry-storage technology from Carlsbad, California-based GenVault Corp. that allows biological specimens to be stored at room temperature. It is a technology that has applications for medical laboratories and pathology groups.
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