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The policy group argued that the tax narrowly targets profit margins of the medical device industry, which would ultimately stifle innovation. Read More
Listing the device would improve the quality of healthcare by enhancing tracking information on implants like cardiac stents and artificial joints, the lawmakers said. Read More
Sens. Chuck Grassley (R-Iowa), Elizabeth Warren (D-Okla.) and three representatives urged the Centers for Medicare & Medicaid Service to begin including information from unique device identifiers (UDIs) for high-risk implants on electronic insurance claims. Read More
The FDA released draft guidance outlining the performance criteria sponsors of certain magnetic resonance coils should use to support substantial equivalence instead of a direct comparison. The guidance applies to sponsors who wish to submit a 510(k) application using the agency’s Safety and Performance Based Pathway. Read More