December 17, 2019
Boston Scientific receives FDA clearance for single-use duodenoscope
Editor's Note
Boston Scientific announced December 13 that it had received Food & Drug Administration (FDA) 510(k) clearance for the EXALT Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures.
The EXALT Model D, which was granted Breakthrough Device Designation from the FDA, eliminates the need for duodenoscope reprocessing and repairs.
The company plans a limited market release of the duodenoscope in the US during the first quarter of 2020.
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