Research & Development
Policy & Regulation
Trends & Finance
FDA clears DeepX Diagnostics digital dermatoscope to screen for suspected skin cancer lesions
The device has conducted more than 180 thousand assessments in pharmacies and primary care clinics in Europe; DeepX is poised to enter the U.S. market.
June 6, 2023
Leica Biosystems granted FDA clearance for Class II mismatch repair panel
The Bond MMR Antibody Panel is available for clinical use on its automated Bond-III and Bond-Max immunohistochemistry instruments.
April 3, 2023
FDA grants 510(k) clearance to DiaSorin for COVID-19 and flu A/B assay
The test detects and differentiates influenza A, influenza B, and SARS-CoV-2 viruses to help ensure physicians can recommend the most appropriate treatment for each patient.
March 20, 2023
Becton Dickinson nabs FDA clearance for infectious vaginitis molecular test
The BD vaginal panel running on the high-throughput BD Cor molecular diagnostic system tests for multiple common types of vaginitis using only a swab and one test.
March 16, 2023
FDA grants clearance to Abbott for first commercial laboratory test to detect traumatic brain injury
The test runs on Abbott's Alinity i laboratory immunoassay instrument, providing a result in 18 minutes to help clinicians quickly assess concussion and triage patients, Abbott said. Negative results rule out the need for a CT scan.
March 7, 2023
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
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
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