FDA Approval

Health and Human Services (HHS) is seeking public comments on making permanent regulatory flexibilities provided during the COVID–19 public health emergency by exempting certain medical devices from premarket notification requirements;...

MEDIA RELEASE First commercial test for fully automated high throughput systems to detect and differentiate SARS-CoV-2, influenza A virus and/or influenza B virus with a single sample As COVID-19 and influenza infections can hardly...

MEDIA RELEASE Detects, confirms and differentiates HIV-1 and HIV-2 infections providing clinicians with critical diagnostic data for personalised management of patients with HIV — from appropriate counseling on disease differences to...