The medical device industry gathered both in person and virtually for this year’s AdvaMed conference, and while the healthcare industry has been reeling from the delta variant surge, topics other than the pandemic were highlighted throughout last week.
The proposed reversal of the Medicare Coverage of Innovative Technology pathway for breakthrough devices was a common theme, with CMS’ chief medical officer defending the decision on the first day. Other topics like the risks ransomware attacks pose to devices, the challenges facing the European Union during the switch to the In Vitro Diagnostics Regulation and the ethics of providing booze to doctors were also discussed.
The pandemic was not completely forgotten, however. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, spoke about how COVID-19 upended CDRH’s goal to reset in 2021 and warned that the heavy coronavirus workload will lead the agency to miss some MDUFA IV performance metrics.