CE mark
Molecular Diagnostics Firm Mainz Biomed Prices $22.5M Follow-on Share Offering
In the first half of this year, the firm intends to launch a clinical study and begin the submission process to obtain FDA clearance for its colorectal cancer diagnostic test.
Canary Molecular POC SARS-CoV-2 Test Nabs CE Mark
The molecular point-of-care test uses biosensors and cloud-based analytics to deliver results within 20 minutes.
NeoGenomics Blood-Based Minimal Residual Disease Test Receives CE Mark
NeoGenomics subsidiary Inivata has also submitted the RaDaR test to the MolDx program in the US for reimbursement.Â
LumiraDx Gets CE Mark for C-Reactive Protein Test
The test is designed to help clinicians make treatment decisions for patients with symptoms of respiratory and other infections.
Indica Labs Gets CE-IVD Mark for Digital Pathology Workflow Software
The software supports tissue-based workflows including digital slide management, primary diagnosis, and secondary consults.
Dec 27, 2021
Dec 3, 2021
Euformatics Gains CE-IVD Mark for OmnomicsNGS
Nov 24, 2021
NGeneBio Gets CE-IVD Mark for HLA Typing Assay
Nov 18, 2021