Search Tag: Sedana Medical
Sedana Medical Receives IND Approval for US Trials
2021 23 Dec
Sedana Medical AB (publ) has announces that the company has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate phase III pivotal clinical trials with its Sedaconda products in the United States. Sedana Medical is aiming for a combination registration of the medical device Sedaconda ACD and... Read more
Sedana Medical Applies for Market Approval in Italy
2021 22 Dec
Sedana Medical AB (publ) has announces that the company has submitted an application for market approval for Sedaconda (isoflurane) for inhaled sedation in intensive care in Italy. “With the application in Italy, we are hoping to bring our Sedaconda products to yet another important European market. Having received market approval in 14 European... Read more
Sedana Medical Presents at ESICM
2021 30 Sep
Sedana Medical AB (publ) has announces that the company will hold a scientific symposium at ESICM Lives 2021, the annual congress of the European Society of Intensive Care Medicine. Additional data on inhaled sedation will also be presented at the congress. ESICM Lives 2021 will be held digitally October 3-6 and Sedana Medical will arrange a scientific... Read more
SEDANA MEDICAL RECEIVES APPROVAL IN GERMANY
2021 28 Sep
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in Germany. The approval applies to the drug Sedaconda (isoflurane) for administration via the medical device AnaConDa (undergoing name change to Sedaconda ACD) for inhaled sedation in intensive care in Germany.... Read more
SEDANA MEDICAL PRESENTING AT ISICEM
2021 30 Aug
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company will host a symposium at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels on August 31-September 3, 2021, where the full details on the Sedaconda study will be presented. In addition, further data on inhaled sedation in COVID-19... Read more
SEDANA MEDICAL'S SEDACONDA STUDY PUBLISHED IN THE LANCET
2021 27 Aug
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the results of the company's pivotal study Sedaconda (SED001) have been published in the highly ranked scientific journal, the Lancet Respiratory Medicine. "We are very pleased that the study is published in Lancet Respiratory Medicine. The results of the study, which is... Read more
SEDANA MEDICAL RECEIVES APPROVAL IN FRANCE
2021 13 Aug
Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announced that the company has received market approval for inhaled sedation in France. The approval applies to the drug Sedaconda (isoflurane)* for administration via the medical device AnaConDa (undergoing name change to Sedaconda ACD) for inhaled sedation in intensive care in France.... Read more
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
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