The SEDASYS is designed to provide intravenous administration of propofol for patients during a colonoscopy or EGD procedure. The system would not require an anesthesiologist to administer the sedative.
ASA has established an ad hoc committee, chaired by Rebecca Twersky, MD, to review the FDA’s restrictions for use. Then the organization’s CEO and chief advocacy officer will meet with J&J representatives regarding supervision, training and post-market studies. Finally, ASA will attempt to work more closely with the FDA’s Center for Device and Radiological Health for future devices.
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