Boston Scientific Receives FDA Clearance For World's First ... | 合法醫療器材資訊網

2019年12月13日—TheEXALTModelDDuodenoscopeisthefirstandonlyFDAclearedsingle-use(​disposable)duodenoscopeonthemarketandwasgranted ...

Boston Scientific Receives FDA Clearance For Worlds First Single-Use Duodenoscope, EXALT™ Model D

U.S. Food and Drug Administration Granted EXALT Model D Single-Use Duodenoscope Breakthrough Device Designation, Expediting Physicians Access to a New, Sterile Device for Each Patient

MARLBOROUGH, Mass., Dec. 13, 2019 /PRNewswire[1]/ -- Boston Scientific Corporation (NYSE: BSX) today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the EXALT™ Model D Single-Use Duodenoscope for use in endoscopic retrograde cholangiopancreatography (ERCP) procedures. The EXALT Model D Duodenoscope is the first and only FDA cleared single-use (disposable) duodenoscope on the market and was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device.

This groundbreaking device has been de...