Search Tag: Jens Lindberg

ICU Management

Sedana Medical Receives Approval for European Dossier

2021 20 Jul

Sedana Medical AB (publ) today announced that the company has received a positive outcome for its European registration application for the drug Sedaconda (isoflurane) for inhaled sedation. Sedaconda is indicated for sedation of mechanically ventilated adult patients during intensive care and should only be administered via the medical device AnaConDa.... Read more

ICU Management

Sedana Medical Announces Positive FDA Interaction

2021 07 Jul

Sedana Medical AB (publ) today announced that the company has completed a successful End of phase II meeting with the US Food and Drug Administration (FDA). The FDA accepted Sedana Medical's proposals for phase III program, including study design and primary endpoints for the studies. This positive outcome means that the company can enter phase III... Read more

ICU Management

Sedana Medical Receives QMS MDR Approval

2021 02 Jul

Sedana Medical AB (publ) today announced that the company has received an approval for its quality system (QMS) according to the EU Medical Device Regulation (MDR) 2017/745. The approval means that Sedana Medical's Class I medical device accessories can continue to be sold with CE marking within the EU. "The new EU Medical Device Regulation (MDR)... Read more