Since the early 2000s next-generation sequencing (NGS Assays) has become an invaluable tool in both drug discovery research and clinical/diagnostic settings.

1930 methods for scientific research application spearheads AI/ML pattern recognition predictive modeling in in vitro diagnostics 80 years later.

Dramatic changes to the regulatory landscape for in vitro diagnostic (IVD) medical devices are in the making. Some of the most impactful changes include a new classification of IVDs, an expansion of post market surveillance and the increased need for Notified Body review. Most medical device manufacturers are aware that failure to meet In Vitro Diagnostic Regulation (IVDR) 2017/746 deadlines can result in either failure to obtain a CE marking or loss of a currently valid CE mark. The deadlines, however, are not written in stone.