FDA Clearance: Page 2

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
Colorectal Cancer Social
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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Basilea gets FDA approval for antibiotic
By LabPulse.com staff writers
Swiss pharmaceutical manufacturer Basilea has received U.S. Food and Drug Administration (FDA) approval for its antibiotic Zevtera (ceftobiprole) for three different types of infections.
April 4, 2024
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BioMĂ©rieux gets FDA 510(k) clearance, CLIA waiver approval for panel
By LabPulse.com staff writers
BioMĂ©rieux's Biofire Spotfire Respiratory/Sore Throat Panel has received dual FDA 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver approval.
March 27, 2024
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Boston Scientific gets FDA approval for drug-coated balloon catheter
By LabPulse.com staff writers
Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for its Agent drug-coated balloon, a paclitaxel-coated balloon catheter sized to fit within blocked or constricted coronary arteries to treat coronary in-stent restenosis.
March 4, 2024
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FDA grants accelerated approval to Iovance’s melanoma cell therapy
By LabPulse.com staff writers
The FDA granted accelerated approval to Iovance Biotherapeutics’ T-cell therapy treatment for unresectable or metastatic melanoma.
February 21, 2024
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T2 Biosystems gets FDA nod to expand bacteria panel
By LabPulse.com staff writers
T2 Biosystems announced it received 510(k) clearance to add A. baumannii to its T2Bacteria Panel.
February 12, 2024
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Why many high-risk IVDs are being reclassified
By LabPulse.com staff writers
The FDA announced that its Center for Devices and Radiological Health (CDRH) will reclassify most in vitro diagnostics (IVDs) that are in the high-risk category to moderate risk to allow their manufacturers an easier path to FDA clearance.
February 1, 2024
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