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The black box warning on GLP-1 receptor agonists stems from animal studies showing C-cell hyperplasia and medullary thyroid cancer in rodents

According to the applicant, the alternative to establishing a new category codeforcing the device into a category like C1763 or C1765would continue the current disincentive for adoption, contradicting CMS's goal of enabling access to worthwhile new therapies, whereas creating a new category code would signal to hospitals that the Axoguard HA+ Nerve Protector TM is recognized as an innovation and encourage appropriate use in patients who need it

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PMID: 37507915