Search Tag: Sedana Medical
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
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
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
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
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
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
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
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
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
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
2021 22 Jun
Sedana Medical AB (publ) today announced that the company's pivotal phase III study Sedaconda (SED001) has been named one of the three best posters at the 52nd intensive care conference DGIIN & ÖGIAIN 16–18 June 2021. "It is very positive that the Sedaconda study is receiving this attention in Germany, which is our largest market. The strong study...Read more
2020 13 Jan
Sedana Medical AB today announced that the last patient has now been included in the pivotal IsoConDa study. Thus, all 300 patients have been included and the study is expected to show top-line results during Q2 2020. “This is a true milestone for Sedana Medical . It is extremely gratifying that we keep the schedule in the world's largest study...Read more