Podcast: Impulse Dynamics CEO Says CMS Breakthrough Rule Could Boost R&D (And Is Good Use Of Tax Dollars)
Following the US Medicare agency’s recent proposed rule to give immediate national coverage for breakthrough devices, Simos Kedikoglou spoke with Medtech Insight about what it could mean for companies like his.
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The long-awaited proposed rule from the US Medicare agency would allow breakthrough products approved by the FDA to get reimbursed, while manufacturers continue to collect clinical and real-world data.
The agency says sponsors of some medical devices that touch skin may no longer need to provide biocompatibility testing data if the materials they’re made of have a safe history.
Medtech experts say despite the hardships many manufacturers are facing due to the coronavirus pandemic, there are opportunities depending on the kind of company.