📢 Good news for the PMA file of our alfapump – the US FDA has accepted our file for completeness in advance of anticipated timing and will now start the in-depth substantive review. Pending FDA approval, which Sequana Medical anticipates in the second half of 2024, alfapump could become the first active implantable medical device in the US for treating liver ascites. Read the full press release here: https://lnkd.in/ejEBCGa3 #sequanamedical #alfapump #PMA #ascites #transforminglives
Thrilled to see your passion for innovation and longevity! Remember what Steve Jobs once said, stay hungry, stay foolish - Let that curiosity lead your path to changing the world for the better. Keep pushing boundaries! 🚀💡🌟
Congrats all of you! The US also desires to use the Alfapump. Hans
Congratulations!
Know your risk!
10moRespect and congratulations to all the involved people in Sequana