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.
Free Daily News
- FBI investigates as Oracle health data breach exposes patient information
- Study: Pulse oximeters may misestimate oxygen saturation in darker skin tones
- FDA issues Class 1 recall for vascular cannulas
- Renewed push for healthcare price transparency faces familiar challenges
- Survey: Tariffs expected to increase hospital costs, disrupt supply chains
- Study: Arthroplasty implants linked to metal accumulation in cerebrospinal fluid
- Novel noninvasive surgical approach shows promise in treating severe OCD
- Study: Preop mental health assessment improves postop outcomes for older patients
- Study: Adenotonsillectomy reduces healthcare use in children with mild sleep-disordered breathing
- Introducing New Leader Toolkit: Your guide to OR leadership success
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement