510(k)
FDA IVD Reclassification Plan May Reduce Regulatory Burden for Test Developers, But Questions Remain
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The plan, announced in January, would reclassify many Class III in vitro diagnostic devices as Class II, impacting companion diagnostic and infectious disease tests.
FDA Approves Thermo Fisher Scientific HLA Typing Kit as CDx for Adaptimmune T-Cell Receptor Therapy
Adaptimmune's therapy is intended to treat patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy.
Proscia Nabs US FDA 510(k) Clearance for Digital Pathology Software
The firm's digital pathology software is used to aid analysis of whole-slide images for the primary diagnosis of cancer.
GenInCode Files FDA 510(k) Submission For Polygenic Cardiovascular Disease Risk Test
The test recently received a CPT PLA code and is currently offered through GenInCode's laboratory in Irvine, California.
Biocartis Nabs FDA 510(k) Clearance for Lynch Syndrome Screening Assay
The Idylla MSI Test identifies microsatellite instability in colorectal cancer tumors to aid in the identification of potential Lynch syndrome.
Nov 12, 2019