News & Updates
Regulatory progress, technology updates and company announcements.
Technology platform update: isothermal amplification + CRISPR POCT and lateral-flow assays
Two technology platforms support our infectious-disease and biomarker testing lines; the R&D pipeline continues to advance.
165 devices listed in the TÜV Rheinland Notified Body confirmation letter; IVDR transition pathway confirmed
Notified Body TÜV Rheinland (NB 0197) issued a confirmation letter: the devices have completed a formal IVDR application with a written agreement in place, and a transition pathway applies under Regulation (EU) 2024/1860.