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FDA Clearance: Page 2
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
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
Siemens Healthineers unveils in vitro diagnostics systems at AACC 2022
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
DiaSorin nabs FDA clearance for infectious disease blood test
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
Exact Sciences subsidiary nabs FDA clearance for CDx
The CDx confirms variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance.
June 29, 2022
Sysmex nabs FDA clearance for addition to analyzer
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
FDA grants approval for Fujirebio assay for Alzheimer's plaques
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
FDA clears COVID-19 test based on breath samples
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
Foundation Medicine nabs FDA clearance for NSLC diagnostic
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
Immunexpress sepsis test gets FDA 510(k) clearance
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
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