The Ledger · Entry 104 · Medicine
Giving the sedation for a routine endoscopy
ContestedSince 2013Criterion practiceLast reviewed 2026-08-17
Event
On 3 May 2013 the FDA granted premarket approval to Sedasys, a system that delivered propofol for light to moderate sedation in healthy adults during colonoscopy and upper endoscopy, watching the patient and cutting the drug on its own.
Johnson and Johnson stopped selling Sedasys in March 2016, less than a year after the rollout. Sales were small, the American Society of Anesthesiologists had campaigned against the device, and the arithmetic its defenders used was blunt, roughly two hundred dollars a procedure with the machine against around two thousand with an anaesthetist. The approval had already been narrowed to healthy patients, simple procedures and light sedation, with an anaesthesia professional required to be reachable. This is the clearest reversal in the register: a machine authorised for a medical act, then withdrawn, and not because it failed. A profession and a market declined it.