The FDA cleared Boston Scientific's EXALT Model D Single-Use Duodenoscope, marking the first time the agency approved a single-use duodenoscope.
The scope was previously awarded Breakthrough Device Designation to get the device to market faster.
The single-use scope is wholly disposable. Duodenoscopes have multiple small and complicated parts that make reprocessing the scopes difficult. While the majority of scopes are properly reprocessed, some organizations have had cross-contamination issues from poorly reprocessed scopes. The FDA recently recommended health systems transition to using scopes with disposable parts or fully disposable scopes.
Boston Scientific will begin selling the devices in the first quarter of 2020.