FDA Clearance: Page 4

Siemens Healthineers unveils in vitro diagnostics systems at AACC 2022
By LabPulse.com staff writers
The system, with the capacity to conduct more than 250,000 clinical chemistry tests per year and more than 25,000 immunoassay tests per year, is in development and under review for potential clearance by the U.S. Food and Drug Administration (FDA), the firm said.
July 26, 2022
2022 07 27 14 51 5076 Doctor Analysis Clinical Samples 400
DiaSorin nabs FDA clearance for infectious disease blood test
By LabPulse.com staff writers
The fully automated test utilizes host response-based data to enable physicians to differentiate accurately between bacterial and viral infections, supporting faster and better-informed treatment and patient management decisions, DiaSorin said.
July 21, 2022
2020 08 27 17 11 6347 Infectious Diseases Research 400
Exact Sciences subsidiary nabs FDA clearance for CDx
By LabPulse.com staff writers
The CDx confirms variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
June 29, 2022
2019 05 22 19 44 5254 Dna Red Laser 400
Sysmex nabs FDA clearance for addition to analyzer
By LabPulse.com staff writers
The analyzer also supports red blood cell and platelet component testing in a single sample aspiration, providing blood processing centers with increased efficiency, consistency, and accuracy, the firm said.
June 14, 2022
2022 06 15 18 37 7431 Xn 1000 Bb Thumbnail
FDA grants approval for Fujirebio assay for Alzheimer's plaques
By Brian Casey
The FDA granted clearance under its breakthrough device pathway to Fujirebio's Lumipulse G β-Amyloid Ratio (1-42/1-40) test, which is designed to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40. These are proteins that can accumulate and form plaques in the brain; concentrations of these proteins can be detected in cerebral spinal fluid (CSF).
May 3, 2022
2022 05 04 20 54 3251 Computer Brain Hemisphere 400
FDA clears COVID-19 test based on breath samples
By LabPulse.com staff writers
The InspectIR COVID-19 breathalyzer test provides results in less than three minutes, according to an FDA news release. It is the first COVID-19 breathalyzer test to receive FDA clearance, with others in development.
April 14, 2022
2019 02 13 19 24 5396 Fda Logo V2 400
Foundation Medicine nabs FDA clearance for NSLC diagnostic
By LabPulse.com staff writers
The test received FDA clearance in February for identifying patients with microsatellite instability-high solid tumors who may benefit from pembrolizumab (Keytruda) treatment. FoundationOne CDx can now also be used as a companion diagnostic to identify patients with NSCLC whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations.
March 17, 2022
2019 10 09 17 32 0093 Dna Cancer Cell 400
Immunexpress sepsis test gets FDA 510(k) clearance
By LabPulse.com staff writers
SeptiCyte Rapid uses reverse transcription polymerase chain reaction to quantify directly from blood the relative expression of genes involved in a patient's immune response, the company said.
November 29, 2021
2019 02 13 19 24 5396 Fda Logo V2 400
BD secures BARDA funds for development of COVID-19 test
By LabPulse.com staff writers
Under terms of the deal, BARDA will extend its support to BD by up to $40.3 million for the development and U.S. Food and Drug Administration (FDA) clearance of five new tests:
November 1, 2021
2019 08 20 21 56 4986 Becton Aacc 2019 400
Thermo Fisher touts product launches at AACC 2021
By LabPulse.com staff writers
For COVID-19, there are two polymerase chain reaction (PCR) tests: the Applied Biosystems TaqPath COVID-19 Fast PCR Combo Kit 2.0 and the Applied Biosystems TaqPath COVID-19 RNase P Combo Kit 2.0. The tests target eight genes across three regions of SARS-CoV-2.
September 28, 2021
2020 05 07 22 15 9104 Thermo Fisher Scientific 400
Techcyte secures $21M in funding
By LabPulse.com staff writers
As part of this effort, the company will use the cash to complete necessary market clearance applications to the U.S. Food and Drug Administration (FDA), it said.
August 22, 2021
2019 05 08 21 57 5547 Pathology Digital Workstation 400
Promega's OncoMate MSI system cleared by FDA
By LabPulse.com staff writers
With the FDA clearance, the company said oncologists and pathologists in the U.S. can now access the IVD test that screens for Lynch syndrome in patients with colorectal cancer.
July 29, 2021
2019 05 22 19 44 5254 Dna Red Laser 400
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