Research & Development
Policy & Regulation
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Copan Diagnostics receives second FDA clearance for semiautomated preanalytical processor
With this second clearance, Colibri can prepare microbial suspensions for antibiotic susceptibility testing with the BioMérieux Vitek 2 system.
October 11, 2022
OIG: FDA recommendations for future pandemics
OIG offered numerous recommendations to manage such infectious disease emergencies, saying the FDA should access and, when appropriate, revise its guidance for Emergency Use Authorization (EUA) submissions for tests.
September 21, 2022
Week in Review: Multicancer early detection at ESMO, DiaSorin nabs FDA clearance for COVID-19 kit, IVD industry urges Congress to enact SALSA, and more
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September 14, 2022
FDA grants 510(k) clearance to DiaSorin for COVID-19 kit
The kit, which runs on DiaSorin's Liaison MDX molecular diagnostics system, provides a sample-to-answer test for the detection of SARS-CoV-2 directly from nasopharyngeal or nasal swab specimens.
September 13, 2022
PixCell Medical, Insight Medical to distribute hematology analyzer
PixCell said that its HemoScreen hematology analyzer delivers lab-grade diagnostics at the point of care without the need for external reagents or extensive training.
September 5, 2022
Cue Health requests FDA de novo clearance for at-home flu test
Clearance would permit the test to be used at home and elsewhere at the point-of-care (POC).
September 1, 2022
DNA forensic evidence frees Ohio man of rape, attempted rape
Low-value prostate cancer screening has Medicare spending ramifications, study finds
‘Good’ cholesterol worse for some adults: NIH study
Empatica receives FDA clearance for digital biomarker platform, closes Series B financing
PerkinElmer launches adeno-associated virus vector detection kits for research
Widespread HbA1c screening enables earlier type 2 diabetes diagnosis in U.K. study
NanoDx, SkyWater launch nano biosensor
The companies said that as a result of the development, NanoDx is ready to prepare and submit the product for review by the U.S. Food and Drug Administration (FDA) with the aim of eventually commercializing a product based on the technology.
August 25, 2022
FDA issues updated reagent, instrument guidance
The agency said that it revised the current guidance to include point-of-care in vitro diagnostic (IVD) devices in certain situations, flowcharts, updates to examples, and further clarification of terminology.
August 15, 2022
Natera files presubmission with FDA for NIPT test
According to the FDA, Q-Subs can serve as helpful tools in the premarket submission process.
August 10, 2022
Abionic nabs IVDR certification for sepsis test
The device detects pancreatic stone protein, an early marker for sepsis, allowing for its identification in about five minutes, Abionic said.
August 8, 2022
Video from AACC: Cytovale immune-response test for sepsis
The San Francisco-based startup has submitted an application to the U.S. Food and Drug Administration (FDA) for clearance of the system and test, which aims to help emergency departments to more effectively and quickly triage patients.
July 28, 2022
FDA clears Angle’s Parsortix breast cancer system
The FDA clearance is the first FDA product clearance to harvest cancer cells from a blood sample for subsequent analysis. This offers the prospect of a new era of personalized cancer care, according to the company.
July 27, 2022
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