Flatlander schreef op 20 mei 2022 16:36:
So what is going on with the FDA review of the Idylla MSI 510K? I can't understand why the delay (13 months and counting). Given the positives such as the following:
1)Abundant head to head performance comparisons published in refereed journals;
2)this is the 3rd or 4th application to FDA (JnJ lead RSV, ImmunExpress Septicyte, and I thought there might have been a Ebola EUA back in like 2015);
3)Professional regulatory staff was hired in the US to interface with FDA.
I have some concerns that Idylla is closely following last years Promega MSI approval.
Hope to hear something on this front soon.