CE mark
Tasso Gets CE Mark for Blood Collection Device
The device, which allows for the self-collection of microliter capillary whole blood samples, was recently cleared by the US Food and Drug Administration.
Agilent CDx Assay IVDR Certified to ID Cancer Patients for Keytruda, Libtayo Treatment
The clearance applies to use of the companion diagnostic to identify patients with multiple cancer types for treatment with Merck's Keytruda and Regeneron's Libtayo.
Geneseeq Nabs CE Marks for Cancer Test Kits
The Toronto-based firm gained marketing clearance in Europe for two kits for profiling solid tumors and one kit for hematological cancer genomic profiling.
DiaSorin Nabs CE Marking for Legionella Immunoassay
The firm said it will sell its Liaison Legionella Urinary Antigen Immunodiagnostic Assay in all countries that accept the CE mark.
Thorne HealthTech Nabs CE Marking for Blood Collection Instrument
The firm said the regulatory authorization will let the firm incorporate the technology into a home-use device for sale across the European Union.