Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Becton Dickinson Gets CE-IVD Mark for High-Throughput COVID/Flu PCR Test
The SARS-CoV-2/flu assay is the second test available on the high-throughput BD Cor PX/MX system.
QuantuMDx Obtains CE Mark for 30-Minute Multiplex Respiratory Panel
The panel, which tests for flu, respiratory syncytial virus, and SARS-CoV-2, expands the company's menu for the molecular Q-POC platform.
Hologic Obtains CE Mark for Molecular Epstein-Barr, BK Virus Assays
The EBV and BK virus tests, the first quantitative assays developed for the Panther Fusion system, expand Hologic’s transplant pathogen monitoring menu.
SeekIn Gets CE Mark for Cancer Treatment Response Monitoring Kit
The test monitors cancer treatment response through shallow whole-genome sequencing of ctDNA and protein analysis.
Angle Gets FDA Clearance for Breast Cancer Cell Isolation System
The system, called Parsortix, has been cleared for use in the isolation of circulating metastatic breast cancer cells for liquid biopsy testing.