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/PRNewswire/ -- Selux Diagnostics, Inc., which is leading a new era in personalized diagnostics to combat superbug infections and fight antibiotic resistance,...
The MCIT/RN Rule was intended to address concerns that delay or uncertainty around Medicare coverage hampered beneficiary access to innovative technologies.
On September 15, 2021, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) published a proposed rule, which (if finalized) would repeal the Agency’s Medicare Coverage...
Centers for Medicare & Medicaid Services CMS proposed rule would repeal Medicare Coverage of Innovative Technology & Definition of Reasonable and Necessary MCIT/R&N final rule; pathway to provide national Medicare coverage of medical devices designated Breakthrough Devices by Food and Drug Administration FDA
Helius Medical Technologies Inc has received Breakthrough Designation from the US Food and Drug Administration for its PoNS device as a temporary treatment of dynamic gait and balance deficits due to symptoms from stroke, it announces.