ARTICLE SUMMARY:
In this week’s roundup: A recovery in FDA novel device approvals in 2020; CMS’ coverage-with-evidence-development policy is under legal review; AdvaMed criticizes EU’s vaccine export controls; Australia cancels COVID-era ventilator and face mask policies; Sen. Warren moves to Finance Committee, and key personnel moves at CMS and FDA.
The legality of CMS’ coverage-with-evidence-development (CED) program is under review at HHS but may be getting new life. FDA is touting record-breaking novel device numbers in 2020, including non-COVID-19 and COVID-19 technology. Also in this week’s Pathways’ Picks: news from Europe, Australia, and Capitol Hill.