After consideration of the public comment we received and our review of the device pass-through application, we have determined that the aprevo Cervical ACDF System does not meet the device category eligibility criterion at 419.66(c)(1) because it is appropriately described by an existing category or a category previously in effect
Many commenters noted the measure requires complex integrations across multiple hospital information systems, including Picture Archiving and Communication Systems (PACS), Radiology Information Systems (RIS), CT consoles, and EHRs, and that much of the necessary data reside in imaging software rather than outpatient EMR systems
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