Sea Change In Medtech As Industry Leans To US For New Innovation
Reimbursement has become a major obstacle to innovation
An expansive study shows the US has emerged over Europe as the preferred launch site for new medical technology because the Food and Drug Administration responds more effectively to innovation than do European regulators.
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The Medical Device and IVD Regulations are much needed, although solutions must be found quickly to address major problems created on the way. But the HTA Regulation works against the sector, MedTech Europe’s Serge Bernasconi said in a recent interview.
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Industry Asks Commission To Delay MDR Full Compliance Dates By At Least Two Years
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