Supreme Court Must Protect Medtech Firms By Upholding Objectively Reasonable Standard, AdvaMed Says
Changing the scienter standard basis by rejecting objective reasonability in FCA claims will hurt medtech innovation, according to AdvaMed.
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The Department of Justice may soon be busy with allegations of pandemic-related fraud and abuse, attorneys predicted in a recent conference presentation.
In this episode, Medtech Insight regulatory reporter Hannah Daniel speaks to Washington Analysis vice president and senior healthcare analyst John Leppard about the Center for Medicare and Medicaid’s Transitional Coverage Of Emerging Technologies pathway, or TCET. He breaks down the pathway and discusses its pros and cons, as well as potential next steps for the agency. We also explore the history of breakthrough device coverage as well as the challenges for coverage of digital health devices.
The approval for Invitae’s cancer risk diagnostic test opens the door for more tests of its kind.