The EXALT Model D Single-Use Duodenoscope is the world’s first commercially available single-use duodenoscope. The duodenoscope has been developed as an alternative to reusable duodenoscopes and to deliver a familiar design in a single-use platform. A single-use scope eliminates the need for reprocessing and repairs and allows physicians to use a new, sterile device for every procedure. The EXALT Model D Single-Use Duodenoscope was granted Breakthrough Device Designation from the FDA. This program was implemented to expedite the development and review process for medical devices that are novel or offer new technology for patients with life-threatening or irreversibly debilitating conditions.