FDA

Boston Scientific receives FDA clearance for single-use duodenoscope, EXALT Model D

Boston Scientific Corporation has 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 an FDA-cleared single-use (disposable) duodenoscope that was granted Breakthrough Device Designation from the FDA to ensure patients and healthcare providers have timely access to this device. ...

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Crohn’s & Colitis Foundation selected for FDA MyStudies app project

The Crohn’s & Colitis Foundation was selected as one of two patient organizations to participate in an U.S. Food & Drug Administration (FDA) Real-World Evidence Program demonstration project using the FDA MyStudies App through the FDA-Catalyst system. The FDA Real World Evidence Program will inform the assessment of the fitness for use of real-world data to support real-world evidence generation for ...

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FDA Revises Safety Alert

Updates Guidance and Clears New/Additional Erbe 24-Hour Port Connector  On April 18, 2018, the FDA released a letter to health care providers regarding the use of 24-hour multi-patient use endoscope connectors. In this letter, it was stated that “the FDA has not received acceptable testing to demonstrate the safe use of these products, and recommends against their use.” The FDA ...

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FDA halts fecal microbiota transplant after patient death

The U.S. Food and Drug Administration has issued a safety communication regarding the use of Fecal Microbiota for Transplantation (FMT) and the risk of serious or life-threatening infections due to transmission of multi-drug resistant organisms (MDROs), as well as protections FDA has determined are needed for patients receiving investigational FMT. Two immunocompromised adults who received investigational FMT developed invasive bacterial infections due ...

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