Regulatory actions in this cycle also spanned approvals and device changes that affect clinical workflows. The FDA approved Denali’s Hunter syndrome therapy, while it also granted an early regulatory pathway shift for melanoma diagnostic devices and electrical impedance spectrometers via reclassification to class II. Separately, Invivoscribe received CE-IVDR certification for its IdentiClone Dx IGH assay, described as the first IVDR-certified test kit for clonal immunoglobulin gene rearrangements in suspected B-cell lymphoproliferative disease. Under EU IVDR risk rules, the assay was designated Class C, and the company said the kit is expected to be commercially available next month. Across both geographies, the updates highlight regulatory execution for both therapeutics and companion diagnostics—critical for rare oncology and complex hematology settings where patient selection drives outcomes.