US FDA Sets Action Date for Sedana Medical's Inhaled Sedation Application

02:06 AM EDT, 08/31/2026 (MT Newswires) -- Sedana Medical (SEDANA.ST) said Monday that the US Food and Drug Administration set April 16, 2027, as the target action date for its new drug application for the administration of isoflurane via the Sedana Medical ACD Delivery System. The FDA set the date under the Prescription Drug User Fee Act. The regulator accepted the application on Aug. 19. The Stockholm-listed medical technology and pharmaceutical company said the submission is supported by its clinical program in inhaled sedation, including the pivotal Inspire ICU-1 and Inspire ICU-2 trials, for mechanically ventilated adult patients in intensive care units.