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This is one of the few studies using human cells, but it is an in vitro model, not a clinical outcome

[38] Unlike previously established device category codes where CMS has made an anatomical specification based on a clear anatomical distinction in the device indication, such as a ureter and the bronchi, a different indication such as drug-delivery rather than angioplasty, or different mechanisms of action like radiofrequency versus ultrasound, with regard to the nominated technology, we did not believe at the time the code was established, nor do we believe at this time, that such an anatomical distinction is necessary for C1831

Brand name pens like Mounjaro and Zepbound use their own fixed concentrations

The injury is clearly localized to one specific area

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et al.) CEUR Workshop Proceedings, Vol