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We noted that neither the FDA 510(k) indication nor the FDA Special 510(k) indication includes the MEMS pressure sensor, and the cleared indications appear to be consistent with the indications for other FDA approved ureteroscopes

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(5) modifying the Excessive Radiation Dose or Inadequate Image Quality for Diagnostic Computed Tomography (CT) in Adults (Hospital LevelOutpatient) eCQM (Excessive Radiation eCQM) from mandatory reporting beginning with the CY 2027 reporting period to continue voluntary reporting in the CY 2027 reporting period and subsequent years

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