Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Geneoscopy Submits PMA Application to FDA for Stool-Based Colorectal Cancer Screening Test
The application is supported by data from the company's prospective trial, demonstrating 94 percent sensitivity for CRC in an average-risk cohort.
Selux Diagnostics Next Generation Phenotyping System Gets FDA 510(k) Clearance
The firm's rapid testing system was cleared along with a Gram-positive bacteria panel determining susceptibility to 14 antimicrobials.
FDA Grants EUA for Scope Molecular Laboratory SARS-CoV-2 Test for Serial Testing
The laboratory-developed test uses RT-PCR to detect SARS-CoV-2 RNA in anterior nasal swab specimens either self-collected or collected by a healthcare professional.
DiaCarta Nabs FDA Emergency Use Authorization for Monkeypox Test
The laboratory-use QuantiVirus MPXV Test Kit targets two regions of the MPXV genome to detect the virus even if mutations occur in one target region.
MedMira Gets CE Mark for COVID, Flu Combo Assay
The test is designed to detect SARS-CoV-2 and influenza A and B in a single nasal swab, according to the Canadian company.