Real-World Evidence Deemed Essential For Breakthrough Designations
A panel of experts in the health care and medical device industries discussed the fate of the Medicare Coverage for Innovative Technology (MCIT) rule during AdvaMed’s annual Medtech Conference.
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Medtech Insight spoke to Rutger Zietsma, Manus Neurodynamica’ CEO, to learn about the next commercial steps for the company's Neuromotor Pen for differential diagnosis of neuromotor impairment.
AdvaMed Urges CMS To Leave MCIT In Place
In a letter to CMS Administrator Chiquita Brooks-LaSure, the industry association argues that repealing MCIT would deny many Americans access to “transformational” medical technologies.
CMS Dashes Industry Hopes For MCIT Rule Any Time Soon
The US Medicare agency has proposed to withdraw a rule that would give temporary automatic coverage to breakthrough devices, stating the rule doesn’t meet its evidence threshold and could put patients at risk.