Sedana Medical NDA accepted for FDA review

What this means

Isoflurane is an inhaled anaesthetic long used in operating rooms in the US. Sedana Medical's application asks the FDA to approve isoflurane, delivered through the Sedaconda ACD device at the ICU bedside, for sedating adults on mechanical ventilators. FDA acceptance starts the formal review clock. If approved, inhaled isoflurane would offer US ICUs a new sedation modality alongside the intravenous drugs propofol and midazolam.