Regulatory News & FDA Approvals
The latest regulatory news and FDA approvals.
Euformatics Gains CE-IVD Mark for OmnomicsNGS
Euformatics has updated the marking on its variant interpretation and reporting software as the firm prepares for the EU's new IVDR scheme.
Audere Gets FDA Emergency Use Authorization for SARS-CoV-2 At-Home Sample Collection Kit
The kit, developed by digital health firm Audere, is designed for the collection of anterior nasal swab specimens for molecular COVID-19 testing in children and adults.
Eurofins Technologies Obtains CE Marks for SARS-CoV-2, Flu, RSV RT-PCR Kits
The firm has launched the two molecular diagnostic kits to detect and differentiate between the three respiratory infections in the same PCR run.
Immunexpress Receives FDA 510(k) Clearance for Sepsis Assay
The assay, which runs on the company's Idylla platform, distinguishes sepsis from noninfectious systemic inflammation.
Novacyt SARS-CoV-2 PCR Test Approved in UK Under New Regulations
The UK recently implemented regulations requiring antigen-based and molecular COVID-19 tests to undergo a desktop review in order to be sold in the region.