FDA Approves Sedasys Computer-Assisted System for GI Propofol Sedation

The FDA has given pre-market approval to Ethicon Endo-Surgery’s Sedasys for its computer-assisted personalized sedation system, the SEDASYS System.

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FDA approves SEDASYS GI sedation system The system provides intravenous administration of propofol for minimal-to-moderate sedation during colonoscopy and EGD procedures. The system is also approved to allow physician-led teams administer propofol, rather than requiring an anesthesiologist to perform the sedation. However, the company will offer the system to “facilities where an anesthesia professional is immediately available for assistance or consultation,” according to the release.

The SEDASYS is designed to reduce over sedation and help healthcare facilities more effectively use limited resources.

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