Search Tag: Sedana Medical

ICU Management

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

ICU Management

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

ICU Management

Introducing Inhaled Sedation in intensive care

2021 09 Nov

Moderator Alexander Kersten Read more

ICU Management

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

ICU Management

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

ICU Management

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

ICU Management

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

ICU Management

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

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