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
- Simple procedure or ‘surgery’? Questionable medical billing practices cause confusion
- Antitrust guideline withdrawal could dampen M&A, boost uncertainty for provider joint ventures
- Surgeons emphasize bariatric surgery benefits amid rising GLP-1 drug popularity
- Study: Geriatric surgery program improves outcomes, independence
- Milestone pig kidney transplant offers hope amid ethical, safety questions
- Fitch Ratings: Hospital credit outlook improves amid stabilizing margins
- Annual Leapfrog Group awards recognize top hospitals, ASCs
- US obesity rates decline for first time in a decade
- Study: Active monitoring without surgery safe for certain low-risk DCIS patients
- Data support option to skip sentinel lymph node biopsy in early breast cancer
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement