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The technology consists of eight cameras that surround a patient, which send live video to a computer workstation that analyzes the video to create a 3D reconstruction of the patient without the need for special clothing, markers, or devices attached to the patient's clothing or skin

Finally, we disagree with the applicant that the evidence for the VersaVue TM Single-Use Flexible Cystoscope is equivalent to that used for Uretero1 TM , and, as we previously explained in the CY 2024 and CY 2025 OPPS/ASC final rules with comment period for Ambu aScope TM 5 Broncho HD (88 FR 81736) and Ambu aScope TM Gastro (89 FR 94182), and as discussed in more detail in our responses to comment, we evaluate all evidence submitted for each device pass-through application as it applies to the nominated device

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