FDA Clearance: Page 2

FDA approves Lilly’s Alzheimer’s disease treatment
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s Kisunla (donanemab) for the treatment of Alzheimer’s disease.
July 3, 2024
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FDA greenlights BioMérieux's mini respiratory, sore throat panel for POC testing
By LabPulse.com staff writers
BioMérieux received special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Biofire Spotfire Respiratory/Sore Throat (R/ST) Panel Mini respiratory viral and bacterial testing device designed for point-of-care (POC) testing.
June 28, 2024
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FDA grants 510(k) clearance to Genetic Signature for parasitic GI infection kit
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Genetic Signature's EasyScreen Gastrointestinal Parasite Detection Kit and GS1 automated molecular workflow.
June 7, 2024
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Roche garners FDA EUA for 4-in-1 respiratory panel
By LabPulse.com staff writers
Roche has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Cobas Liat SARS-CoV-2, influenza A/B, and RSV nucleic acid test.
June 10, 2024
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Diasorin receives FDA 510(k) clearance for fungal infection panel
By LabPulse.com staff writers
Diasorin has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new Liaison Plex Yeast Blood Culture assay, the second molecular multiplexing panel developed for the firm's Liaison Plex system.
June 6, 2024
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BioMérieux TBI test receives FDA 510(k) clearance
By LabPulse.com staff writers
BioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its assay that screens for mild traumatic brain injury, including concussion.
May 29, 2024
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Amgen gets FDA approval for small cell lung cancer therapy
By LabPulse.com staff writers
Amgen announced on Thursday that the U.S. Food and Drug Administration (FDA) has approved its therapy tarlatamab, to be marketed under the name Imdelltra, for the treatment of extensive-stage small cell lung cancer (ES-SCLC).
May 17, 2024
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Qiagen gets FDA clearance for respiratory syndromic testing panel
By LabPulse.com staff writers
Qiagen announced that it has received U.S. Food and Drug Administration (FDA) clearance for its QIAstat-Dx respiratory syndromic testing panel for clinical use.
May 14, 2024
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Geneoscopy receives FDA approval for CRC screening test
By LabPulse.com staff writers
Geneoscopy announced that the U.S. Food and Drug Administration (FDA) has approved ColoSense, the firm's noninvasive multitarget stool RNA colorectal cancer (CRC) screening test.
May 7, 2024
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Leica Biosystems, Sectra receive FDA 510(k) clearance for digital pathology system
By LabPulse.com staff writers
Leica Biosystems has received 510(k) clearance from the U.S Food and Drug Administration (FDA) for its Aperio GT 450 DX digital pathology system, in conjunction with Sectra's digital pathology software.
May 2, 2024
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Pillar Biosciences gets FDA approval for NGS solid tumor profiling test
By Matt Limb
Pillar Biosciences has announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its OncoReveal CDx pan-cancer next-generation sequencing (NGS) test for general solid tumor profiling.
April 26, 2024
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Prenosis gets FDA authorization for AI-based sepsis diagnostic tool
By LabPulse.com staff writers
The U.S. Food and Drug Administration (FDA) has granted de novo marketing authorization to artificial intelligence (AI) healthcare firm Prenosis' AI-based ImmunoScore sepsis risk-assessment software.
April 8, 2024
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