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Sedasys set for US approval after panel vote

This article was originally published in Clinica

Executive Summary

A system designed by Ethicon Endo-Surgery to deliver the anaesthetic propofol has been recommended for US approval by an FDA advisory panel. The Anesthesiology and Respiratory Therapy Devices Advisory Committee voted 8 to 2 in favour of approval of the Sedasys system, which is used during colonoscopies to diagnose colorectal cancer. The panel suggested that, if approved, Sedasys should only be used in adults aged under 70, and that a comprehensive training program and a post-approval study should be put in place. The device is the first computer-assisted personalised sedation (CAPS) system, Johnson & Johnson subsidiary Ethicon claims.

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