J&J submits PMA for personalized sedation
This article was originally published in The Gray Sheet
Executive Summary
Ethicon Endo-Surgery unit of Johnson & Johnson submits PMA application to FDA for its Sedasys computer-assisted personalized sedation system. The device is intended for use by physician/nurse teams to administer minimal to moderate doses of propofol to sedate patients undergoing colonoscopies for the diagnosis and screening of colorectal cancer, as well as upper gastrointestinal disorders. The PMA is supported by a 1,000-patient, U.S. trial randomizing Sedasys to the current standard of care, which consists of physician-administered benzodiazepine and opioids